NewMedical Director of Quality – Heart & Vascular RWJBarnabas HealthMedical Director of Quality – Heart & VascularWest Orange, NJWorking in close partnership with the VP for Quality, Heart & Vascular, this leader will leverage data and registry insights to drive performance improvement, oversee clinical event reviews and regulatory compliance, and engage physicians and multidisciplinary teams in fostering a culture of accountability, collaboration, and continuous improvement. RWJBarnabas Health, the largest integrated healthcare system in New Jersey, is seeking a Medical Director of Quality – Heart & Vascular to serve as a key clinical leader driving quality, safety, and performance excellence across our system.
NewDirector, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
Associate Director, External Supplier QA GMP Daiichi Sankyo, Inc.Associate Director, External Supplier QA GMPBasking Ridge, NJ$153,600–$230,400 / yearFull timeCross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations. Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.
Director, Risk Based Quality Management (RBQM) Daiichi Sankyo, Inc.Director, Risk Based Quality Management (RBQM)Basking Ridge, NJ$201,840–$302,760 / yearFull timeOversee RBQM activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee Central Risk Managers to ensure proper implementation and execution of RBQM and inspection readiness. Interacts with and influences internal and external executive level and study level stakeholders on risk based quality management principles, process improvement, metrics design and application and other key drivers of enhanced quality.
Associate Director PV Quality, Americas Daiichi Sankyo, Inc.Associate Director PV Quality, AmericasBasking Ridge, NJ$153,600–$230,400 / yearFull timeProvide operational QA leadership for the respective CSPV teams, including Quality Oversight for the Quality Plan execution, review of key CSPV regulatory documents, Health Authority Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective CSPV functional areas. Interact with senior CSPV leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process.
NewDirector, Data Governance & Security Princeton UniversityDirector, Data Governance & SecurityPrinceton, NJReporting to the Associate Vice President for Data Strategy & Innovation, the Director will be responsible for supporting University Advancement’s engagement efforts and overseeing an enterprise-wide role-based approach to data access through data governance, data management, and data security policies and practices. Data Strategy & Innovation is dedicated to housing, managing, analyzing, and disseminating information and data to inform Advancement strategy, foster strong relationships with donors, volunteers, and campus partners, and promote effective integration.
NewAssistant Director of Nursing Care-OneAssistant Director of NursingParsippany, NJ$114,000–$145,000 / yearAlong with the Director of Nursing, promote positive employee relations, strong customer service ethic and commitment to ongoing staff education and training, May exercise direction over the department in the absence of the Director of Nursing. Assist the Director of Nursing with regulatory compliance and ensure effective communication strategies with all levels of nursing staff to promote effective care delivery.
NewAssistant Director of Nursing - RN Care-OneAssistant Director of Nursing - RNHamilton Township, NJ$91,000–$95,000 / yearAlong with the Director of Nursing, promote positive employee relations, strong customer service ethic and commitment to ongoing staff education and training, May exercise direction over the department in the absence of the Director of Nursing. Assist the Director of Nursing with regulatory compliance and ensure effective communication strategies with all levels of nursing staff to promote effective care delivery.
Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets. Interpret evolving FDA regulations, guidances, enforcement trends, compliance letters, and relevant industry developments, including ambiguous or precedent-setting issues, and translate them into actionable regulatory strategy and business guidance.
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
NewDirector of Social Services Care-OneDirector of Social ServicesParamus, NJ$81,000–$100,000 / yearEnsures and documents that residents/families have input into the care planning process; Acts as liaison between residents, families, outside agencies, and the Center Administrator to ensure that the resident's rights are maintained; Takes responsibility for conducting family meetings as needed; functions in a management capacity and adheres to all policies and procedures of the Center as a representative of CareOne Administration; Performs administrative requirements such as completing necessary forms and reports under the direction of the Administrator and submitting such reports to the Administrator and/or consultants as required; Facilitates discharge planning including the development of an organized discharge plan for all customers; Concerns self with the safety of all Center residents in order to minimize the potential for fire and accidents. Also ensures that the Center adheres to legal, safety, health, fire, and sanitation codes by being familiar with his/her in carrying out the Center's fire, safety and disaster plans and by being familiar with current MSDS; Puts customer service first and adheres to the CareOne Culture of Excellence Pledge.
Associate Director, Regulatory (RIM) Business Systems and Operations Daiichi Sankyo, Inc.Associate Director, Regulatory (RIM) Business Systems and OperationsBasking Ridge, NJ$157,920–$236,880 / yearFull timeThe Associate Director, Business Systems & Operations Management will function at various times as a manager of one or more business systems, as a leader of sub-teams or workstreams within larger projects or programs, as a contributor within various systems-related working groups, and as a senior business analyst, as required. The Associate Director, Business Systems & Operations Management is responsible for managing the operational, administrative, and tactical support of assigned business systems; as well as contributing to projects and initiatives that optimize the use of information technology to achieve departmental, divisional, and enterprise business objectives.
Senior Director, Clinical Safety MD Daiichi Sankyo, Inc.Senior Director, Clinical Safety MDBasking Ridge, NJ$280,350–$467,250 / yearFull timeThe individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.
Associate Director, Clinical Science Daiichi Sankyo, Inc.Associate Director, Clinical ScienceBasking Ridge, NJ$162,400–$243,600 / yearFull timeUnder supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge preferred.
Associate Director, Biostatistics (Late Stage) Daiichi Sankyo, Inc.Associate Director, Biostatistics (Late Stage)Basking Ridge, NJ$175,440–$263,160 / yearFull timeProtocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. May participate in meeting or teleconferences with Health Authorities Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
Associate Director, Global Oncology Marketing, Biomarker Strategy Daiichi Sankyo, Inc.Associate Director, Global Oncology Marketing, Biomarker StrategyBasking Ridge, NJ$162,400–$243,600 / yearFull timeCritical responsibilities include contribution to the brand plan, providing commercial input to CDx team, development of tactics such as education to laboratories/pathologists, drive quality initiatives, ensuring adequacy of testing supply in markets and coordinating all activities with regional teams. Apply expertise to challenge strategic and tactical assumptions and refine diagnostic strategies across the product lifecycle, considering competitive pressures, disease prevalence(s), test proficiency / quality assurance, and market access dynamics.
Medical Director in Freehold, NJ TeamHealthMedical Director in Freehold, NJFreehold, NJPart timeOur comprehensive clinical and operational leadership team will support your transition into our medical practice with a comprehensive 3-month onboarding program along with a dedicated clinical field mentor and support from industry leading clinical experts in post-acute medicine. The medical practice is part of TeamACO, a dedicated long-term Accountable Care Organization participating in the Medicare Shared Savings Program for our clinicians, which could result in you receiving a portion of the shared savings if certain criteria are met.
Director, Early Phase Biostatistics Daiichi Sankyo, Inc.Director, Early Phase BiostatisticsBasking Ridge, NJ$201,840–$302,760 / yearFull timeMentoring and Coaching Junior Statisticians: Mentoring the study level statisticians for the assigned projects to ensure optimal statistical handling and quality deliverables including Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR). Drug Development Strategy: Provides input to the clinical development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies’ requirements for countries and regions the drug is to be submitted.
NewExecutive Director, Oncology R&D, Global Clinical Lead Daiichi Sankyo, Inc.Executive Director, Oncology R&D, Global Clinical LeadBasking Ridge, NJ$329,025–$548,375 / yearFull timeClinical Monitoring Planning: Oversees and coordinates Sponsor oversight of CRO clinical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL) Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of clinical Monitoring activities; Defines or contributes to department level surveillance activities across projects Study strategy: Interacts with leaders of each function to develop study strategy; Approves project or TA-level TM and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; Attends regulatory agency meetings and leads clinical strategy discussions Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level Study Outputs: For large-studies/programs, consults on responses to IRBs and HA; Has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions External collaboration: Ensure continuous, effective alignment within / between CRO and vendors; For large, multiple indication project in late development, develops and leads Ad-Board with top tier KEEs for project level strategic advice; Develops and leads steering committee for Phase 3 registrational study; Consults with KEEs for advice on complex development or safety issues; Maintains and leads external collaborations and advisory panels at department level People Management: Assign staff with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight; Monitor and manage direct report’s performance in such roles, ensuring that there is proper understanding of task complexity and management of key risks; Participate in department’s planning for staff and cross-functional staffing plans for the Therapeutic Area. Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept.
Emergency Medicine Assistant Medical Director in Edison, NJ TeamHealthEmergency Medicine Assistant Medical Director in Edison, NJEdison, NJFull timeThis leadership opportunity is ideal for a board-certified or board-eligible emergency physician who is passionate about clinical excellence, physician engagement, operational performance, and advancing quality patient care in a high-acuity community hospital setting. As assistant medical director, you will partner closely with the medical director and hospital leadership to support the clinical, operational, and strategic success of the emergency department while maintaining an active clinical practice.
NewPhysical Therapy Director Strive Physical TherapyPhysical Therapy DirectorPrinceton, NJ$82,000–$115,000 / yearResponsible for the management of daily clinic operations including patient care, employee management and overseeing administrative duties in order to ensure both high quality patient care and meet the financial goals of the clinic. Responsibilities Plan goals and objectives annually for office operations and identify the resources (staff, equipment, funds) required to meet or exceed the goals set for the clinic.
NewDirector of Advanced Heart Failure & Transplant RWJBarnabas HealthDirector of Advanced Heart Failure & TransplantNewark, NJProgram Leadership: Provide medical direction for our Heart Transplant, Advanced Heart Failure, and Mechanical Circulatory Support program, ensuring excellence in clinical outcomes and regulatory compliance (UNOS/CMS). RWJBarnabas Health treats over 3 million patients a year across eleven acute care hospitals-including Newark Beth Israel, RWJUH, Jersey City Medical Center, and Cooperman Barnabas Medical Center.
NewAdult Congenital Heart Disease (ACHD) Cardiologist – Medical Director RWJBarnabas HealthAdult Congenital Heart Disease (ACHD) Cardiologist – Medical DirectorNewark, NJp>Our partnership with Rutgers University creates the state’s largest academic healthcare system dedicated to providing high-quality patient care, leading-edge research, and world-class health and medical education, further advancing our mission of providing high-quality healthcare in New Jersey. With 12 acute care hospitals, 3 children‘s hospitals, a growing number of our outpatient facilities and physician practices, our healthcare system is committed to providing the highest quality of patient care and health education to the community and region.
NewExecutive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).
Director, FPandA Page GroupDirector, FPandAPrinceton, NJ$160,000–$180,000 / yearFull timeOur client is a market-leading consumer goods and retail organization and one of the largest retailers in the United States (within their field), with a strong presence across both wholesale and e-commerce channels. This is a highly visible role working directly with the CFO and senior leadership team, partnering closely with both commercial and operational stakeholders across the organization.
NewAdministrative Assistant to the Director Fabuwood Cabinetry CorpAdministrative Assistant to the DirectorIronbound, NJThis role owns reporting follow-up, meeting coordination, department communication, and task tracking while working closely with managers across Custom Shop, CNC, Illume/Pantry, and other operational teams. Create, update, and improve reports, workflows, and tracking systems using Asana, Teams, Microsoft Excel, Microsoft Word, and company systems.
NewFood Service Director AramarkFood Service DirectorTrenton, NJ$70,000–$80,000Aramark Student Nutrition provides food and nutrition services to over 350 school districts in the U.S. It offers public and private education institutions a variety of dining options including breakfast and lunch programs, after-school snacks, catering, nutrition education and retail operations. BENEFITS: Aramark offers comprehensive benefit programs and services for eligible employees including medical, dental, vision, and work/life resources.
Director of Quality Control / Quality Assurance (Food Manufacturing) SourcePro SearchDirector of Quality Control / Quality Assurance (Food Manufacturing)Hackensack, New JerseySourcePro Search is conducting a search for an experienced Director of Quality Control / Quality Assurance to lead and manage our quality programs in a fast-paced, high-volume food manufacturing environment. The ideal candidate is a certified SQF Practitioner with a proven track record of successful third-party, regulatory, and customer audits, and extensive experience in both foodservice and retail segments.
Director Quality and Performance Improvement St. Joseph HealthDirector Quality and Performance ImprovementPaterson, NJThe Director of Quality and Performance Improvement serving as a the leader of quality improvement initiatives will identify opportunities for improvement in care, upon access, during treatment, and transition of care accomplished through the collaborative efforts of multidisciplinary teams, Clinical Services, Ancillary Support Services, and Contracted Services. Scope of practice will include, but is not limited to the Provider Peer Review process, CMS inpatient and outpatient hospital reporting, (inclusive of value-based programs), Leapfrog Hospital Survey, NJ DOH quality reporting, proportionate shared programs, and Pay for Reporting incentive programs.
Director of Quality Enser CorporationDirector of QualityClifton, NJA well-established precision manufacturer in the aerospace and defense sector is seeking a Director of Quality to lead its quality management systems across casting, machining, and assembly operations. Collaborate with cross-functional teams (engineering, operations, supply chain) to improve process capability and product quality.
Director of Quality Phaxis LLCDirector of QualityClifton, NJOversee dimensional and metallurgical inspection processes, including CMM, and GD&T, Drive root cause analysis and implement corrective and preventive actions (RCCM, 8, CAPA). i 10 years of progressive quality leadership experience in aerospace, defense, or high-precision manufacturing.
NewQuality Assurance Director - GMP ESO Biotechnologies Recordati SpAQuality Assurance Director - GMP ESO BiotechnologiesBridgewater, NJIn relation to this job, the QA Director GMP ESO Biotechnologies will be in charge of budget associated to the External Biomanufacturing activity in their perimeter and will manage direct report(s) in order to ensure that the tasks/activities he/she is responsible for are carried out on time and in full. Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop Corrective and Preventive Action Plans (CAPAs), addressing root causes.
Quality Director TDK CorpQuality DirectorNJ$150,000–$180,000 / yearThis entails: • Periodic Management Review of QMS for achieving a close loop continuous improvement • Corrective and preventive measures for product and process defects and nonconformities • Internal audits against SOPs to ensure adherence to QMS • Inspection and testing of products and periodic verification that these SOPs are effective in producing consistent product quality • Data collection and report generation to provide failure rate, yields, cycle time, and other metrics for continuous improvement • Management of calibration system for test equipment, instruments, gauges, and tools • Segregation of nonconforming products, parts, and material and appropriate disposition. The key components of SQM/SQA are: • Developing/maintaining Supplier evaluation process • Developing/maintaining Supplier Quality Assurance Manual • Supplier audits • Quality and environmental compliance of parts and material • On-time delivery • Continuous cost reduction through process improvement and application of Lean principles • Responsiveness for lead time, schedule changes to meet end customers' expectations and proactive preventive measures for issues experienced by TDK-Lambda.
Quality Assurance Director, Clarkson Estates CAMBAQuality Assurance Director, Clarkson EstatesStaten Island, NYFull timeWho We Are: CAMBA is a community of staff, volunteers, clients, donors, neighbors and partners who work together to build an inclusive New York City, where all children and adults have access to the resources and supports they need to thrive. Obtain “Criminal History Checks” (CHC) fingerprinting through the New York State Office of Mental Health (OMH) and the Justice Center for the Protection of People with Special Needs (Justice System) and Staff Exclusion List (SEL) clearance.
Sr. Director of Quality Operations Harrow IncSr. Director of Quality OperationsNJMembers of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world - providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. Strong computer skills in Microsoft Office Suite, database management, and documentation preparation (Word, PowerPoint, Excel, and others must be able to learn additional software and programs, as required).
Executive Director, Microbiology Quality Sterility Assurance Bristol-Myers Squibb CoExecutive Director, Microbiology Quality Sterility AssuranceNew Brunswick, NJ$260,860–$316,097 / yearThis position brings critical expertise in sterility assurance, microbiological controls, and contamination control strategy across BMS's internal and external commercial and PD manufacturing sites - spanning pharmaceutical, biopharmaceutical, cell therapy and radiopharmaceuticals. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Director, R&D Quality Intelligence & Transformation Bristol Myers SquibbDirector, R&D Quality Intelligence & TransformationNew Brunswick, NJ$201,430–$244,089 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
NewQuality Director TDK-Lambda Americas IncQuality DirectorNeptune, NJ$150,000–$180,000 / yearPart timeGENERAL PURPOSE OF THE JOB: To develop TDK-Lambda Americas initiatives to create a Total Quality Culture and to champion the design and achievement of its goals with respect to quality of products and services across multiple product lines, manufacturing facilities, product design locations and a global supply chain. Final authority related to quality decision making for accept/reject for internal and supplier related issues, stop and start of production line for quality issues, receiving inspection issues, piece part issues when interpretation of criteria is required.
Director, Business Operations, Global Quality Bristol-Myers Squibb CoDirector, Business Operations, Global QualityNew Brunswick, NJ$190,060–$230,308 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Additionally, the role is accountable for developing and implementing portfolio resource management strategies, driving financial accountability, and fostering a culture of quality, agility, and operational excellence across the organization.
NewDirector Quality and Patient Safety Hunterdon HealthDirector Quality and Patient SafetyFlemington, NJNational Performance Goals) Actively participates in regulatory and accreditation visits Demonstrates strong human resources and fiscal management skills Other duties as assigned Qualifications Minimum Education: Required: Bachelors Degree in nursing or healthcare related field Preferred: Masters Degree in nursing or healthcare related field Minimum Years of Experience (Amount, Type and Variation): Required: Minimum of 3 years nursing or healthcare related clinical experience Minimum 5 years experience in leadership in a hospital or healthcare system Experience working with regulatory agencies Preferred: License, Registry or Certification: Required: Registered Nurse (RN) Preferred: Certificate and/or Advanced Specialized Training in healthcare quality and patient safety Knowledge, Skills and/or Abilities: Required: Highly visible and comfortable assessing and articulating vulnerabilities of operations to prevent error Excellent data analytics and reasoning skills Attentive to detail with a high level of accuracy Exercise sound judgment and strong organizational and project management skills Ability to present and report information to all levels of the organization Strong leadership skills that emphasize collaboration and positive relationships. Primary Position Responsibilities Assumes responsibility for clinical outcomes across the health system Implements a physician quality improvement evaluation system with supporting structures including but not limited to FPPE, OPPE, and peer review Assesses and articulates vulnerabilities of operations to prevent errors Collaborates with key stakeholders (clinical staff, supporting departments, leadership, etc.) to advance quality and patient safety; assists clinical teams and supporting departments with performance improvement projects Actively participates in key quality and safety committees including Quality Council; leads patient safety rounds Leads comprehensive root cause analyses and oversees incident reporting processes to identify systemic issues, drive corrective actions, and improve patient safety outcomes.
Quality Director TDK-Lambda AmericasQuality DirectorNeptune, New JerseyGENERAL PURPOSE OF THE JOB: To develop TDK-Lambda Americas initiatives to create a Total Quality Culture and to champion the design and achievement of its goals with respect to quality of products and services across multiple product lines, manufacturing facilities, product design locations and a global supply chain. Final authority related to quality decision making for accept/reject for internal and supplier related issues, stop and start of production line for quality issues, receiving inspection issues, piece part issues when interpretation of criteria is required.
Sr. Director, External Manufacturing Quality, Cell Therapy Bristol-Myers Squibb CoSr. Director, External Manufacturing Quality, Cell TherapyNJ$238,200–$288,637 / yearTo define and shape the Quality strategy for global Contract Manufacturing Organizations (CMO) and associated Contract Test Labs (CTLs) management for the Cell Therapy External Manufacturing (ExM) network and to ensure a high level of cGMP compliance and the safety, efficacy, and quality of externally manufactured commercial products. To build relationships with senior leadership in the CMO and CTL network to support the Virtual Plant Teams (VPTs) and Virtual Analytical Teams (VATs) and to proactively manage and improve CMO Quality performance through risk-based oversight and periodic reviews.
Associate Director, Quality Risk Specialist (GCP) Bristol-Myers Squibb CoAssociate Director, Quality Risk Specialist (GCP)New Brunswick, NJ$163,850–$198,543 / yearProject Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines. The Associate Director, RBQM will mainly be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management.
Associate Director, Quality Risk Management Bristol-Myers Squibb CoAssociate Director, Quality Risk ManagementNJ$175,310–$212,438 / yearProject Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines. As part of the upstream protocol authoring process, partner with Drug Development, in particular the CORM function, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.
Associate Director, HRBP, Site Quality Global Business Unit Bristol Myers SquibbAssociate Director, HRBP, Site Quality Global Business UnitPrinceton, NJ$161,840–$196,112 / yearThis role helps to shape and execute the people strategy required to deliver a high-performing, compliant, and engaged workforce within a complex manufacturing and quality environment, under supervision of the Executive Director, HRBP, Global Business Unit and the Executive Director, HRBP Global Quality ‑performing, compliant, and engaged workforce within a complex manufacturing and quality environment. The HRBP serves as a critical connector across multiple GPDS functions, collaborating closely with Manufacturing Operations, Site Quality, and global Centers of Expertise (CoEs) to enable organizational effectiveness, workforce planning, talent management, and culture transformation.
Associate Director, Quality Systems & Compliance (Design Controls) Merck & Co IncAssociate Director, Quality Systems & Compliance (Design Controls)Rahway, NJ$129,000–$203,100 / yearActivities include attending Topic 3.3 Community of Practice (CoP) meetings, QMS Chapter 3 meetings, MDCP Site Communication meetings, and Document Control Technical Committee meetings to ensure compliance with current Good Manufacturing Practices (cGMPs), ISO 13485 requirements, and other Global Health Authority Regulations. Job Description Brief Description of Position The Associate Director Quality Systems & Compliance within Device Quality & Regulatory will support our company's Manufacturing Division QMS Topic 3.3 - MDCP Design Controls and lead continuous improvement initiatives that support every aspect of our business processes, systems, and data.
Director, Quality Control Ferring Pharmaceuticals IncDirector, Quality ControlParsippany, NJ$158,136–$194,472 / yearAs Director, Quality Control you will be responsible for strategic leadership and oversight of the Quality Control (Analytical and Microbiology) function, including testing at contract labs for drug substance, drug product, and stability programs across commercial and development portfolios. Partner cross-functionally with Pharmaceutical Development, Technical Operations, QA, and CMC Regulatory Affairs to manage method transfers, validations, and data oversight aligned with development and production timelines.
Medical Director Hospital Quality Capital HealthMedical Director Hospital QualityPennington, NJWhen determining base salary and/or rate, several factors may be considered including, but not limited to location, years of relevant experience, education, credentials, negotiated contracts, budget, market data, and internal equity. Capital Health is a dynamic health care resource accredited by the DNV that includes two hospitals, an outpatient center, satellite ED, and an expansive network of primary and specialty care.
Associate Director, Quality Control Lantheus Holdings IncAssociate Director, Quality ControlSpringfield, NJ$139,000–$232,000 / year12+ years' experience of progressively more responsible laboratory management in a related scientific/technical discipline or equivalent combination of education and relevant experience in the pharmaceutical industry, related GMP environment, or equivalent. Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes.