Director, Brand PR (Onsite - Boca Raton, FL) BraintrustDirector, Brand PR (Onsite - Boca Raton, FL)San Francisco / Bay Area, CAThe right candidate will bring deep consumer PR and earned media experience, strong people leadership, in-house brand-side experience, and the ability to translate brand priorities into earned media impact across traditional media, culture outlets, social-first news channels, partnerships, experiential moments, product launches, and consumer storytelling. This leader will serve as the day-to-day owner of Brand PR performance across the U.S. portfolio, partnering closely with the SVP of Communications, Brand Marketing leaders, and external agency partners to ensure each brand shows up in culture with relevance, credibility, and consistency.
NewTravel Nurse RN - Director of Nursing - $3,287 per week in Pleasanton, CA Advantis Medical StaffingTravel Nurse RN - Director of Nursing - $3,287 per week in Pleasanton, CAPleasanton, CA$3,287–$3,287Advantis Medical, the #1 rated travel nurse agency, is currently seeking an experienced Director of Nursing Registered Nurse (RN) for an exciting new travel job in Pleasanton, CA 94588. If you are an experienced Director of Nursing Registered Nurse (RN) with a passion for providing exceptional patient care, just let us know you’re interested.
NewTravel Nurse RN - Director of Nursing - $3,432 per week in Palo Alto, CA Advantis Medical StaffingTravel Nurse RN - Director of Nursing - $3,432 per week in Palo Alto, CAPalo Alto, CA$3,432–$3,432Advantis Medical, the #1 rated travel nurse agency, is currently seeking an experienced Director of Nursing Registered Nurse (RN) for an exciting new travel job in Palo Alto, CA 94303. If you are an experienced Director of Nursing Registered Nurse (RN) with a passion for providing exceptional patient care, just let us know you’re interested.
NewSenior Program Director, Commercial Regulatory Affairs JouléSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$120–$122.40 / hourSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Lead Program Review Committees (PRCs) independently, managing complex product launches and cross-functional activities.
NewPhysician - Medical Director, Community Based Outpatient Clinic Supervisor Position in Livermore,... Veterans Health AdministrationPhysician - Medical Director, Community Based Outpatient Clinic Supervisor Position in Livermore,...Livermore, CA$303,077–$325,000 / yearAt VA Palo Alto Health Care System, Livermore VA Community Based Outpatient Clinic, we stress the principles of servant leadership; the Medical Director will benefit from training and gain experience in effective communication, data management, and process improvement for success on the front line. The opportunity to serve as a Medical Director for a Community Based Outpatient Clinic VA Primary Care Clinic and work with a dynamic, collaborative, and engaged local leadership team to manage high quality & efficient health care on site.
NewClinical Resource Director - Healthcare HCA HealthcareClinical Resource Director - HealthcareSan Jose, CA$87,547.20–$148,824Develops relationships and collaborates with facility leadership and staff, physicians, and supply chain to identify, develop and implement continuous quality improvement and cost containment processes for supplies, technology and labor practice. The Clinical Resource Director has a broad enterprise and segment influence and will need to build strategic alliances with Hospital Leadership, Physicians and Supply Chain to execute successfully the clinical supply expense plan.
NewClinical Value Analysis Director HCA HealthcareClinical Value Analysis DirectorSan Jose, CA$87,547.20–$148,824Develops relationships and collaborates with facility leadership and staff, physicians, and supply chain to identify, develop and implement continuous quality improvement and cost containment processes for supplies, technology and labor practice. The Clinical Resource Director has a broad enterprise and segment influence and will need to build strategic alliances with Hospital Leadership, Physicians and Supply Chain to execute successfully the clinical supply expense plan.
NewClinical Resource Director HCA HealthcareClinical Resource DirectorSan Jose, CA$87,547.20–$148,824Develops relationships and collaborates with facility leadership and staff, physicians, and supply chain to identify, develop and implement continuous quality improvement and cost containment processes for supplies, technology and labor practice. The Clinical Resource Director has a broad enterprise and segment influence and will need to build strategic alliances with Hospital Leadership, Physicians and Supply Chain to execute successfully the clinical supply expense plan.
NewMedical Director Primary Care Physician - Family Medicine/ Internal Medicine UCSFMedical Director Primary Care Physician - Family Medicine/ Internal MedicineSan Francisco, CA$245,000–$287,000 / yearProximity and Access to UCSF and Leading Medical Resources: Practicing in San Francisco through UCSF offers the best of both worlds: a community-focused practice where physicians develop long-term relationships with patients, backed by the resources and academic strength of a premier medical institution. Support for Work-Life Balance: With its scenic parks, nearby beaches, and recreational trails, the Bay Area encourages a healthy lifestyle and provides opportunities to unwind outside of work.
NewMedical Director - Family Medicine Clinic AMN Healthcare, Inc.Medical Director - Family Medicine ClinicSan Leandro, CA$325,000–$350,000 / yearAn established organization committed to improving the quality of life for low-income residents in the Bay Area is seeking a board-certified or board-eligible family medicine or internal medicine physician with proven experience to serve as our Primary care Medical Director. At AMN Healthcare, we strive to be recognized as the most trusted, innovative, and influential force in helping healthcare organizations provide quality patient care that continually evolves to make healthcare more human, more effective, and more achievable.
NewAssociate Medical Director (Pleasanton, CA) MDstaffersAssociate Medical Director (Pleasanton, CA)Pleasanton, CA$240,000–$250,000 / yearCompensation Range: $240k - $250k, plus applicable incentive compensation, benefits, etc. • We assist with scheduling interviews and provide resources to simplify the licensing process.
NewMedical Director (Oakland, CA) MDstaffersMedical Director (Oakland, CA)Oakland, CA$150,000–$175,000 / yearCompensation Range: $150k - $175k for full-time providers, plus applicable incentive compensation, benefits, etc. • We assist with scheduling interviews and provide resources to simplify the licensing process.
Hospitalist Assistant Medical Director in San Jose, CA TeamHealthHospitalist Assistant Medical Director in San Jose, CASan Jose, CA$145–$159 / hourFull timeWe are seeking an experienced hospitalist with leadership capabilities for Regional Medical Center, a thriving hospitalist program located in the heart of tech mecca, San Jose, California. Competitive Compensation, with an estimated base salary range of $145 to $159 hourly, RVU and quality bonus, plus leadership stipend, with the opportunity to earn additional incentives.
Medical Director Ambassador - Hospital Medicine - Traveling - Nationwide VituityMedical Director Ambassador - Hospital Medicine - Traveling - NationwideEmeryville, CAEnsure practice is appropriately represented and demonstrates their value through leadership roles (as applicable) and/or participation with hospital management, medical staff leadership, Medical Executive, Medical Staff and other hospital committees, and within the local community. Strategize and execute a comprehensive annual practice management plan that sets clear goals and objectives, continuously surpassing expectations and delivering value to patients, clients, providers, and the local community.
Medical Director - Psychiatry - Mills-Peninsula Medical Center VituityMedical Director - Psychiatry - Mills-Peninsula Medical CenterBurlingame, CASutter Mills-Peninsula Medical Center earned five stars, the highest ranking possible, in the CMS Overall Hospital Quality Star Ratings and an Outstanding Patient Experience Award, placing it among the top 15 percent of hospitals in patient experience. Ensure practice is appropriately represented and demonstrates their value through leadership roles (as applicable) and/or participation with hospital management, medical staff leadership, Medical Executive, Medical Staff and other hospital committees, and within the local community.
Manager/ Director of Quality Assurance CRYSTAL PHARMATECH INCManager/ Director of Quality AssurancePleasanton, CA10+ years of relevant regulatory affairs experience in the bioanalytical CRO or biotechnology/pharmaceutical industry, or a combination of education and experience. Crystal Bio Solutions, a member of Crystal Pharmatech, is a leading biologics analytical organization with operations in the San Francisco Bay Area and New Jersey.
Director of Quality Engineering Netskope IncDirector of Quality EngineeringSanta Clara, CAThis is a high-impact technical leadership role perfect for a hands-on seasoned QE leader who has experience running large quality engineering and tool development organizations. Oversee the long term testing / pre-production environment strategy, ensuring high availability and stability for testing environments used by the entire company.
Senior Director of Quality Assurance Jones Lang LaSalle IncSenior Director of Quality AssuranceSan Francisco, CA$192,000–$210,000 / yearData and Metrics Governance • Understand and support existing key performance indicators (KPIs) and quality metrics to ensure process improvements align with organizational objectives • Assess impact of proposed system and data changes on established governance frameworks and data integrity • Collaborate with data governance teams to evaluate risks and opportunities related to metrics and reporting when implementing process changes • Analyze performance data to identify trends, opportunities, and areas for improvement while maintaining alignment with existing measurement systems. • Model: Operational Excellence Focus • Location: San Francisco Bay Area preferred; other northern California locations considered • Success Metrics • Successful implementation of quality improvement initiatives • Measurable improvements in operational KPIs and process efficiency • Effective stakeholder engagement and cross-functional collaboration • Timely completion of assigned projects and deliverables • Knowledge transfer and capability building within client organization.
Director of Quality Management Full Time Knight Health Holdings LLCDirector of Quality Management Full TimeSan Leandro, CA$116,000–$147,000 / yearKindred Hospital San Francisco Bay Area is a 99-bed long-term acute care hospital offering the same in-depth care you would receive in a traditional hospital, but for an extended recovery period. Maintains oversight responsibility for all regulatory body surveys, including The Joint Commission (TJC), State Licensing Reviews, and CMS Validation surveys.
Manager/ Director of Quality Assurance Crystal PharmatechManager/ Director of Quality AssurancePleasanton, CaliforniaOur guiding principle of "getting the crystal form and formulation right the first time for Phase I" not only expedites the progression of your molecule to IND filing and Phase I clinical trials, but also minimizes the necessity for human PK bridging studies. Our key differentiator is our integrated and specialized services, including API solid-state research, crystallization, preformulation, formulation development and manufacturing, clinical supply.
Compliance QA Director Exelixis IncCompliance QA DirectorAlameda, CA$190,000–$269,000 / yearActs as the Subject Matter Expert for current global regulatory compliance expectations and proactively reviews changes in regulatory requirements and industry environment that would necessitate future changes and drives completion of impact assessments. Responsible for setting the strategic plan for maintaining organizational inspection readiness across the organization and developing an annual inspection readiness plan, ensures activities are completed, and drives continuous improvement initiatives.
NewDirector, Quality Engineering netSkopeDirector, Quality EngineeringSanta Clara, CA$147,000–$299,500 / yearSince 2012, we have built the market-leading cloud security company and an award-winning culture powered by hundreds of employees spread across offices in Santa Clara, St. Louis, Bangalore, London, Paris, Melbourne, Taipei, and Tokyo. Our core values are openness, honesty, and transparency, and we purposely developed our open desk layouts and large meeting spaces to support and promote partnerships, collaboration, and teamwork.
Executive Director of Quality - IP Synopsys IncExecutive Director of Quality - IPSunnyvale, CAThe Team you will be part of: You'll join the IP Group Quality team-a highly collaborative, cross-functional unit focused on driving high-impact quality initiatives across Synopsys' silicon IP portfolio. As a leader, you inspire trust, drive clarity, and champion continuous improvement, enabling Synopsys' IP Group to deliver world-class products with uncompromising quality.
Director of Quality Excellence PHILDirector of Quality ExcellenceSan Francisco, CaliforniaRemoteThrough its digital stakeholder experiences, patient access services, market access solutions, and distribution models, pharma manufacturers can deliver affordable and timely therapy access to patients, resulting in more patients staying on their treatment plans longer. Demonstrated ownership of software quality assurance for operational or customer-facing platforms, including test automation, release validation, and partnering with Engineering on defect prevention and resolution.
Director, Quality Assurance Insitro IncDirector, Quality AssuranceSouth San Francisco, CA$205,000–$218,000 / yearWe work hard to bring together diverse teams-grounded in a wide range of expertise and life experiences-and work even harder to ensure those teams thrive in inclusive, growth-oriented environments supported by equitable company and team practices. These powerful models rely on extensive biological and computational infrastructure and allow insitro to advance novel targets and patient biomarkers, design therapeutics and inform clinical strategy.
Director Quality Assurance Imperative CareDirector Quality AssuranceCampbell, CAFull timeWhat You’ll Bring: Bachelor’s degree in engineering or related discipline and a minimum of 10 years of progressive responsibility in quality assurance in a medical device, regulated or robotics setting, plus a minimum of 3 years of prior people management experience; or equivalent combination of education and work experience. As a key leader, this role takes part of strategic conversations and activities that include building a quality infrastructure aimed at transferring operations from concept to manufacturing in collaboration with robotics upper management and consultants.
Associate Director, GCP QA Mirum PharmaceuticalsAssociate Director, GCP QAFoster City, CaliforniaProvide quality oversite for the GCP/GVP/GLP vendor activities, including internal/external deviations, CAPAs, change controls, and KPIs/KQIs. 10-12 years of experience in the pharmaceutical industry, including 5-10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants.
Senior Director, Validation and Quality Engineering Allogene Therapeutics IncSenior Director, Validation and Quality EngineeringSouth San Francisco, CA$230,000–$270,000 / yearLed by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease.
Associate Director, Quality Data Science Allogene Therapeutics IncAssociate Director, Quality Data ScienceSouth San Francisco, CAIn this role, you will report to the head of Validation and Quality Engineering, and you will be responsible for developing and leading the Quality Data Science/Quality Engineering function to embed the principles and practices of applied statistics, data science and machine learning to further Allogene's efforts in leading the establishment of an allogeneic CAR T platform, and to provide guidance and data driven insights across Allogene's programs. Provide direction and input to project teams utilizing the principles of applied science and statistics to drive strategies for process and analytical understanding and overall product quality control, including approaches for product comparability, process validation, product monitoring, stability trending and lifecycle management/improvement.
Senior Director, Validation and Quality Engineering Allogene TherapeuticsSenior Director, Validation and Quality EngineeringSouth San Francisco, CA$230,000–$270,000 / yearLed by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease.
NewAssociate Director, Quality Data Science Allogene TherapeuticsAssociate Director, Quality Data ScienceSouth San Francisco, CA$170,000–$210,000 / yearIn this role, you will report to the head of Validation and Quality Engineering, and you will be responsible for developing and leading the Quality Data Science/Quality Engineering function to embed the principles and practices of applied statistics, data science and machine learning to further Allogene’s efforts in leading the establishment of an allogeneic CAR T platform, and to provide guidance and data driven insights across Allogene’s programs. Provide direction and input to project teams utilizing the principles of applied science and statistics to drive strategies for process and analytical understanding and overall product quality control, including approaches for product comparability, process validation, product monitoring, stability trending and lifecycle management/improvement.
NewSr. Manager / Associate Director, Quality Audits Personalis IncSr. Manager / Associate Director, Quality AuditsFremont, CA$165,000–$210,000 / yearRoot Cause & Investigation Leadership: Provide expert guidance and lead cross-functional investigation teams in executing comprehensive root cause analyses for CAPAs, deviations, and non-conformances stemming from internal and external audits. The successful candidate will have strong leadership skills and possess extensive experience managing Quality Management Systems (QMS) within highly regulated environments, driving compliance, governance, and continuous improvement across the organization with a high degree of autonomy.
NewAssociate Director / Senior Manager, Quality Assurance AllakosAssociate Director / Senior Manager, Quality AssuranceRedwood City, CaliforniaAssociate Director / Senior Manager, Quality Assurance Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Position Summary: As a member of the Allakos team you will be responsible for quality oversight activities related to Method Validation, Release testing, and Stability for Drug Substance and Drug Product.
Senior Director, Quality Operations, Service and Repair, Americas Olympus CorpSenior Director, Quality Operations, Service and Repair, AmericasSan Jose, CAIn accordance with published service manuals and product risk documents, ensure implementation of effective service and repair work instructions, process controls, validation, calibration, maintenance, critical component evaluations, quality inspections, and return of product to customers. Proactively lead quality in support of Service and Repair activities across the Americas region, including oversight of regional 3rd party contractors, and work with operations to ensure right first-time quality and compliance with all applicable laws and regulations.
Director of Quality Assurance, Clinical Caribou Biosciences, Inc.Director of Quality Assurance, ClinicalBerkeley, CA$220,000–$235,000 / yearProvide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline. The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP, PV, and GLP focused team settings and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies.
Senior Director of Technical QA (GMP) Summit TherapeuticsSenior Director of Technical QA (GMP)Palo Alto, CaliforniaHARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. The Senior Director QA will report to the Vice President, Quality Assurance and Regulatory CMC, and provide comprehensive GMP quality oversight across the full chemistry, manufacturing, and controls (CMC) lifecycle for Summit’s oncology pipeline.
Payer Quality Consultant, Director PricewaterhouseCoopers LLPPayer Quality Consultant, DirectorCAAs a Director, you drive business growth by overseeing multiple projects, cultivating executive-level client relations, and mentoring the future leaders. Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: • Lead in line with our values and brand.
Director Quality Assurance Imperative Care IncDirector Quality AssuranceCampbell, CA$234,000–$244,000 / yearWhat You'll Bring: Bachelor's degree in engineering or related discipline and a minimum of 10 years of progressive responsibility in quality assurance in a medical device, regulated or robotics setting, plus a minimum of 3 years of prior people management experience; or equivalent combination of education and work experience. As a key leader, this role takes part of strategic conversations and activities that include building a quality infrastructure aimed at transferring operations from concept to manufacturing in collaboration with robotics upper management and consultants.
Director, Quality Performance / Job Req 956626885 Alameda Alliance for HealthDirector, Quality Performance / Job Req 956626885Alameda, CA$167,440–$251,160 / yearThis role will work cross-functionally to implement quality initiatives to achieve state and national benchmarks for National Committee for Quality Assurance (NCQA) Healthcare Effectiveness Data and Information Set (HEDIS), Centers for Medicare & Medicaid (CMS) Star Ratings, Department of Health Care Services Medi-Cal Managed Care Accountability Set, and Department of Managed Health Care (DMHC) Health Equity and Quality Measure Set. PRINCIPLE RESPONSIBILITIES: Under the general direction of the Senior Director, Quality, the Director, Quality Performance is responsible for developing, coordinating, implementing, and managing the strategic quality performance programs across multiple lines of businesses including Medi-Cal, Dual Eligible Special Needs Program (D-SNP), and Group Care).
Director, Quality (Clinical) Braveheart BioDirector, Quality (Clinical)San Francisco, CaliforniaThe Director of Quality will serve as a senior quality leader for Braveheart Bio and will be responsible for clinical quality oversight, clinical data integrity, GCP inspection readiness, and support of nonclinical quality activities as needed for our late-stage clinical program in hypertrophic cardiomyopathy (HCM). This leader will partner closely with Clinical Development, Regulatory, Biometrics, PV, Data Management, Medical, Legal and external CRO and vendor partners to ensure effective, inspection-ready clinical quality oversight across all programs.
Associate Director, GCP QA Mirum Pharmaceuticals IncAssociate Director, GCP QAFoster City, CA$190,000–$205,000 / year10-12 years of experience in the pharmaceutical industry, including 5-10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants. Provide quality oversight for the GCP/GVP/GLP vendor activities, including internal/external deviations, CAPAs, change controls, and KPIs/KQIs.
Director, Quality Systems Align Technology, Inc.Director, Quality SystemsSan Jose, CAOversee the harmonization of quality system processes at various global sites included in the scope of the Invisalign quality system including internal audits, document control, risk management, non-conformance and corrective action handling, inspections, training, and management review. The successful candidate will partner with Align Global QMS leaders to create a quality management infrastructure that is compliant, effective, efficient, agile, and that supports a rapidly growing business with complex and diverse product lines (both hardware and software).
Director, Quality Control Oruka Therapeutics IncDirector, Quality ControlMenlo Park, CA$213,000–$240,000 / yearRole Overview: The Director, Quality Control - Combination Products will provide strategic and operational leadership for the Quality Control function supporting late-stage clinical development, analytical testing oversight for clinical drug substance and drug product, process performance qualification (PPQ), regulatory submissions, and commercial launch readiness for monoclonal antibody drug products and combination products, including pre-filled syringes and autoinjectors. Strong knowledge of cGMP regulations and global regulatory expectations, including 21 CFR Parts 210, 211, and 4. Hands-on experience supporting combination products such as pre-filled syringes, autoinjectors, or related delivery systems.
Associate Director, QA Computer System Validation Cytokinetics IncAssociate Director, QA Computer System ValidationSouth San Francisco, CA$184,500–$215,250 / yearThis role will hare strategic responsibility for the QA CSV / CSA function to support cross-functional and QA goals for GXP systems and deliver results for corporate initiatives, as well as independently drive and own multiple complex CSV-related projects in partnership with multiple cross-functional leaders. Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
Associate Director, Clinical Quality Denali Therapeutics IncAssociate Director, Clinical QualitySouth San Francisco, CA$193,638–$224,270 / yearThe Associate Director, GCP Clinical Quality will play a key role in ensuring the successful execution of Denali's clinical trials by delivering strategic quality oversight and fostering a culture of compliance and continuous improvement. Key Accountabilities/Core Job Responsibilities: Serve as a GCP Quality team member on Study Execution Teams (SETs) and deliver a cohesive strategic GCP framework across Denali clinical trials.
Senior Director Clinical Quality and Policy Delta Dental of California Inc.Senior Director Clinical Quality and PolicySan Francisco, CADDS or DMD required Active, unrestricted dental license, or ability to obtain appropriate licensure if required Minimum of 10 years of transformational leadership experience in dental, managed care, health plan, payer, or related healthcare environments Significant experience in clinical quality, utilization management, clinical review, and clinical policy Demonstrated experience in both direct clinical care and administrative leadership Experience applying evidence-based practice, clinical research, or scientific literature to clinical policy, quality, or care model decisions Proven ability to influence senior leaders and work effectively across a complex, matrixed organization Strong strategic thinking and ability to translate clinical expertise into business and operational impact Senior-level leadership experience in clinical quality, clinical policy, utilization management, or related roles within a health plan, healthcare organization, or integrated care environment. Advanced knowledge of managed care principles Verbal and written communication skills Dental background and knowledge of dental managed care Strong Organizational and retention skills Must gave strong attention to detail and ability to handle multiple concurrent tasks with constant interruptions Successful presentation and negotiation skills Ability to maintain confidentiality Ability to coordinate activities over large service areas Demonstrated capability to interface & maintain effective relationships with all levels of management and business partners Demonstrated analytical & problem solving skills and experience at both a strategic and functional level.
Director External Quality Assurance Ultragenyx Pharmaceutical IncDirector External Quality AssuranceSouth San Francisco, CA$215,600–$266,300 / yearThe Director, CMC QA will report to the Senior Director of CMC QA and be responsible for maintaining strategic responsibility over QA Manufacturing Operations, developing and implementing Ultragenyx CMC Quality approach for assigned programs, and working with colleagues to improve processes utilized to ensure product quality. In this role, in collaboration with key stakeholders in Technical Operations, DIR CMC QA provides quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines.
Associate Director of Global Quality Antheia IncAssociate Director of Global QualityMenlo Park, CARemoteAntheia is seeking an experienced and driven Associate Director of Global Quality to provide hands-on quality leadership across our regulated starting material (RSM) and pharmaceutical active pharmaceutical ingredient (API) operations. Maintain current knowledge of evolving GMP regulations, ICH guidelines, and DEA requirements relevant to controlled substance API and RSM manufacturing; communicate changes and impact assessments to leadership.
Director, Clinical Quality Assurance Corcept Therapeutics IncDirector, Clinical Quality AssuranceRedwood City, CALead, manage, and train others on GCP audits, including clinical investigative site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs). The Director of Clinical Quality Assurance (CQA) is a senior member of the CQA team and will lead and perform day-to-day clinical quality operations and compliance activities to support the success of the clinical studies sponsored or supported by Corcept.
Director, GMP Quality Assurance Oruka Therapeutics IncDirector, GMP Quality AssuranceMenlo Park, CA$213,000–$240,000 / yearReview and approve GMP documentation, including master batch records, executed batch records, analytical methods, specifications, validation protocols and reports, tech transfer documentation, stability protocols and reports, and risk-assessment documentation. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year.