Director of Clinical Quality Integrated Resources, IncDirector of Clinical QualityCambridge, MassachusettsContractorPerson must be able to coordinate other QA contractors for auditsMust also be able to deliver SOP's and processes andThis is ONLY in the GCP area Must have GCP experience Must have Pharma Experience within Quality Assurance Coordinating audits (internal, external) Inspection experience (FDA) Need to have worked in a development program so they know how to coordinate audits for a development programJob Description:Job Title: Director, Vaccines Clinical Compound Support Quality Assurance OBJECTIVES: • Plays a leadership role in ensuring that investigator, vendor, facility and system audits are conducted, for communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented. EXPERIENCE, KNOWLEDGE AND SKILLS: Knowledge and Skills: In-depth knowledge of the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidances and Computer System Validation • Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
Director, Quality Assurance (Operations) Zevra Therapeutics IncDirector, Quality Assurance (Operations)Boston, MA10+ years of progressive experience in pharmaceutical/biotech industry with expertise in establishing effective and efficient systems and processes supporting pre-clinical, clinical and commercial programs, 7+ years of Quality leadership experience with a successful track record in vendor oversight and managing relationship with external stakeholders as well as internal QA systems in a virtual environment, 7+ years' experience in the establishing and administering of GCP-, GLP- and GDP compliant systems, Bachelors or Advanced degree in a scientific or related discipline, Understanding of worldwide requirements of GxP compliance and quality systems for clinical and commercial products, Leadership role in the management of regulatory/health authorities inspections, Experience with new product launch and implementation of serialization systems and commercial product complaint processes is a plus, Strong team player that has a customer service approach and is solution oriented, Ability to travel both domestically and internationally as needed, likely to be ~10 15%, The candidate will need to embrace Zevra's mission and core values, Ability to effectively communicate with inspiration, lead and influence individuals from multiple functional departments at all levels of the organization, Strong organizational and time management skills to balance working on multiple projects and initiatives in parallel, A proven self-starter capable of high performance with limited direction and oversight, Excellent people leader with strong mentorship skills. This includes, but is not limited to, audit planning and execution, reporting and coordination with external contractors, Supports periodic GxP training and ensure that training requirements are consistently met, as required, In collaboration with Head of Quality and other department heads, prepare, review, approve, and implement SOPs as required, Responsible for Quality Review Boards, providing technical expertise for product quality decisions, Responsible for manufacturing investigations, in collaboration with the Manufacturing Team, ensuring appropriate corrective and preventive actions are taken as required, Support continuous improvement initiatives to optimize Zevra's quality and compliance position, Cross-train and serve as back-up for Quality Systems, as assigned.
Director of Quality Engineering - Growth and Corporate Functions Segment Humana IncDirector of Quality Engineering - Growth and Corporate Functions SegmentMARemote$156,600–$215,400 / yearWork at Home Requirements: To ensure Home or Hybrid Home/Office employees' ability to work effectively, the self-provided internet service of Home or Hybrid Home/Office employees must meet the following criteria: At minimum, a download speed of 25 Mbps and an upload speed of 10 Mbps is required; wireless, wired cable or DSL connection is suggested. Decisions are typically related to the implementation of new/updated programs or large-scale projects for the function and supporting technical/operational procedures and processes, and implements strategic plans, drives goals and objectives, and improves performance.
NewDirector of Quality Systems Elucid Bioimaging IncDirector of Quality SystemsBoston, MARemote$175,000–$225,000 / yearDeep hands-on experience guiding software development lifecycle activities in an agile environment with monthly releases (testing strategy, design transfer, release processes, etc.), working with Product and Engineering teams to maintain compliance and champion a culture of quality. We are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs.
Quality Director, Single Use Division - Flexible Operations Sites Thermo Fisher Scientific IncQuality Director, Single Use Division - Flexible Operations SitesWaltham, MA$160,000–$218,250 / yearThe Quality Director for the Single Use Division (SUD) Flexible Operations Sites is responsible for leading and advancing the quality strategy, culture, compliance, and operational excellence across multiple manufacturing and operations sites supporting flexible single-use technologies and products. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Director of Quality - Semiconductor - Peabody, MA Michael Page InternationalDirector of Quality - Semiconductor - Peabody, MAPeabody, Massachusetts$170,000–$220,000 / yearFull timeLead Global Quality Strategy For A Growing Semiconductor LeaderOne of our best clients, who we have made several placements at is a highly respected technology organization recognized for developing advanced equipment used within some of the world's most innovative manufacturing environments. Contact Taylor Rankin Quote job ref JN-072026-7058458Job SummarySectorEngineering & ManufacturingSub SectorQuality, TechnicalIndustryIndustrial / ManufacturingLocationPeabodyContract TypePermanentConsultant NameTaylor RankinJob ReferenceJN-072026-7058458
Associate Director, Global Quality Risk Management BiogenAssociate Director, Global Quality Risk ManagementCambridge, Massachusetts$155,000–$214,000 / yearRegular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. Reporting to the Director of Quality Risk Auditing & Governance, you will be the primary enterprise lead for the execution of QRM, ensuring that risk-based thinking is interwoven into our Quality Management System (QMS), operational decision-making processes, and organizational culture.
NewDirector of Quality and Regulatory - Transplantation Services and VAD Lowell General HospitalDirector of Quality and Regulatory - Transplantation Services and VADBoston, MA$122,301.82–$155,933.24 / yearMinimum Qualifications: Master's degree in Nursing, Healthcare Administration, Public Health, or a related health science field OR; Bachelor's degree in Nursing, Public Health, or a related field AND Eight (8) years of related experience in quality and regulatory functions within a healthcare setting. A management role that supervises employees focusing on tactical, operational activities within a specified area, with the majority of time spent overseeing area of responsibility, planning, prioritizing and/or directing the responsibilities of employees.
Director Of Quality Michael Page InternationalDirector Of QualitySalisbury, Massachusetts$165,000–$195,000 / yearFull timeJob SummarySector: Engineering & ManufacturingSub Sector: Quality, TechnicalIndustry: Industrial / ManufacturingWhere: SalisburyContract Type: PermanentConsultant Name: Kyle PerryJob Reference: JN-072026-7075170 The Successful ApplicantBachelor's degree in Engineering or a related technical discipline; Master's degree preferred.15+ years of progressive leadership experience within Quality Assurance.
Director, Quality Control TScan TherapeuticsDirector, Quality ControlWaltham, MA$210,000–$220,000 / yearThe submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics’ internal Talent Acquisition team. Reporting to the Associate Vice President of QC and AD, the ideal candidate should have relevant experience in compendial, cellular, molecular, and environmental monitoring in a cGMP facility, and enjoy fast-paced, collaborative, and vibrant culture.
Associate Director, Quality Systems - Cell and Gene Therapies (VCGT) Vertex PharmaceuticalsAssociate Director, Quality Systems - Cell and Gene Therapies (VCGT)Boston, Massachusetts$148,000–$222,000 / yearThe Quality Systems Associate Director supports strategicdesignofand ensures tactical execution of quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy (VCGT) organization. Responsible for strategic, Risk Management monitoring support, and Data Integrity initiatives and activities to drive prioritization and in-support continuous improvement across VCGT QMS/Compliance processes .
Associate Director, Quality Systems - Cell And Gene Therapies (Vcgt) Vertex Pharmaceuticals, IncAssociate Director, Quality Systems - Cell And Gene Therapies (Vcgt)Boston, MA$148,000–$222,000 / yearThe Quality Systems Associate Director supports strategic design of and ensures tactical execution of quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy (VCGT) organization. Responsible for strategic, Risk Management monitoring support, and Data Integrity initiatives and activities to drive prioritization and in-support continuous improvement across VCGT QMS/Compliance processes.
Director, IT R&D and Quality Applications Amylyx PharmaceuticalsDirector, IT R&D and Quality ApplicationsCambridge, MARemote$206,000–$232,000 / yearAdditional responsibilities will include a range of activities within the information technology organization including project management, development, and maintaining procedures to ensure Amylyx has a stable, robust, and scalable set of applications to support the changing business needs and support. In this role you will lead the strategy, delivery, and lifecycle management of systems supporting Research, Clinical Development, Data Management, Biometrics, Regulatory, Pharmacovigilance, and Quality functions.
Director, IT R&D And Quality Applications Amylyx PharmaceuticalsDirector, IT R&D And Quality ApplicationsCambridge, MARemote$206,000–$232,000 / yearAdditional responsibilities will include a range of activities within the information technology organization including project management, development, and maintaining procedures to ensure Amylyx has a stable, robust, and scalable set of applications to support the changing business needs and support. If outside of the New England region, you will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving or public transportation.
Director, IT R&D and Quality Applications Amylyx Pharmaceuticals IncDirector, IT R&D and Quality ApplicationsCambridge, MARemote$206,000–$232,000 / yearAdditional responsibilities will include a range of activities within the information technology organization including project management, development, and maintaining procedures to ensure Amylyx has a stable, robust, and scalable set of applications to support the changing business needs and support. In this role you will lead the strategy, delivery, and lifecycle management of systems supporting Research, Clinical Development, Data Management, Biometrics, Regulatory, Pharmacovigilance, and Quality functions.
Associate Director, Quality Operations Amylyx PharmaceuticalsAssociate Director, Quality OperationsCambridge, MARemote$172,000–$194,000 / yearProvide QA review and approval on quality technical agreements, master production records, product specifications (in-process, release, and stability), analytical method qualification/validation documents, method transfer documents, and stability plans. Lead or participate in regular meetings internally and externally as CMC Quality SME to ensure Amylyx's quality expectations are met in the areas of Good Manufacturing Practice, Good Distribution Practice, and Good Documentation Practice.
Associate Director, Quality Operations Amylyx Pharmaceuticals IncAssociate Director, Quality OperationsCambridge, MARemote$172,000–$194,000 / yearProvide QA review and approval on quality technical agreements, master production records, product specifications (in-process, release, and stability), analytical method qualification/validation documents, method transfer documents, and stability plans. Lead or participate in regular meetings internally and externally as CMC Quality SME to ensure Amylyx's quality expectations are met in the areas of Good Manufacturing Practice, Good Distribution Practice, and Good Documentation Practice.
Director, Quality Assurance (Operations) Zevra TherapeuticsDirector, Quality Assurance (Operations)Boston, Massachusetts10+ years of progressive experience in pharmaceutical/biotech industry with expertise in establishing effective and efficient systems and processes supporting pre-clinical, clinical and commercial programs, 7+ years of Quality leadership experience with a successful track record in vendor oversight and managing relationship with external stakeholders as well as internal QA systems in a virtual environment, 7+ years’ experience in the establishing and administering of GCP-, GLP- and GDP compliant systems, Bachelors or Advanced degree in a scientific or related discipline, Understanding of worldwide requirements of GxP compliance and quality systems for clinical and commercial products, Leadership role in the management of regulatory/health authorities inspections, Experience with new product launch and implementation of serialization systems and commercial product complaint processes is a plus, Strong team player that has a customer service approach and is solution oriented, Ability to travel both domestically and internationally as needed, likely to be ~10 15%, The candidate will need to embrace Zevra’s mission and core values, Ability to effectively communicate with inspiration, lead and influence individuals from multiple functional departments at all levels of the organization, Strong organizational and time management skills to balance working on multiple projects and initiatives in parallel, A proven self-starter capable of high performance with limited direction and oversight, Excellent people leader with strong mentorship skills. This includes, but is not limited to, audit planning and execution, reporting and coordination with external contractors, Supports periodic GxP training and ensure that training requirements are consistently met, as required, In collaboration with Head of Quality and other department heads, prepare, review, approve, and implement SOPs as required, Responsible for Quality Review Boards, providing technical expertise for product quality decisions, Responsible for manufacturing investigations, in collaboration with the Manufacturing Team, ensuring appropriate corrective and preventive actions are taken as required, Support continuous improvement initiatives to optimize Zevra’s quality and compliance position, Cross-train and serve as back-up for Quality Systems, as assigned.
NewAssociate Director, Clinical Quality Compliance Stoke Therapeutics, Inc.Associate Director, Clinical Quality ComplianceBedford, MA$192,000–$215,000 / yearThis person will support Stoke's clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all Stoke clinical and bioanalytical studies. This person will be responsible for establishing Stokes inspections management program for GCP inspections and expected to be influential towards maturing Stoke's quality culture and help reach a sustained state of inspection readiness.
Associate Director, GMP Quality Formation Bio IncAssociate Director, GMP QualityBoston, MA$161,500–$202,000 / yearRecognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients.
Associate Director, Analytical Development & Quality Control Alpha-9 Oncology IncAssociate Director, Analytical Development & Quality ControlBoston, MAThe successful candidate will manage relationships with external manufacturing and testing partners while partnering closely with Quality, Regulatory, Technical Operations, and Program Leadership teams to support API development, CMC activities, and timely execution of clinical supply strategies. Alpha-9 Oncology is seeking a highly experienced and motivated Associate Director, Analytical Development & Quality Control, to provide technical and operational leadership for QC activities supporting our clinical-stage radiopharmaceutical programs.
Senior Director, Analytical Development & Quality Control Rhythm PharmaceuticalsSenior Director, Analytical Development & Quality ControlBoston, MA$210,000–$300,000 / yearYou will lead and develop a high-performing organization while overseeing external partners, including CDMOs, CROs, and contract laboratories, to deliver analytical development and QC activities across drug substance and drug product. As the Senior Director, Analytical Development and Quality Control, you will provide strategic and technical leadership for analytical development and quality control across Rhythm's portfolio, spanning discovery through commercialization and lifecycle management.
Director of Clinical Quality and Resident Care (RN license required) Rogerson BrandDirector of Clinical Quality and Resident Care (RN license required)Boston, Massachusetts$135,000–$150,000 / yearServe as a clinical resource to executive leadership on resident care, clinical operations, healthcare trends, and best practices for Resident Care, Memory Care, and Adult Day Health programs. ·Partners with Executive Directors, Directors of Nursing, Nurse Managers, and Clinical Care Coordinator to promote clinical excellence, operational consistency, and high-quality resident outcomes.
Director_Manufacturing Quality Consultant_ Life Sciences PricewaterhouseCoopers LLPDirector_Manufacturing Quality Consultant_ Life SciencesBoston, MA$155,000–$410,000 / yearDemonstrates some proven abilities to collaborate and work with a diverse team including: Basic problem solving and analysis skills; Financial modeling skills; Basic spreadsheet, presentation and document development skills; Demonstrates the ability to build, maintain, and utilize networks of client relationships; Interpersonal skills and proactive communication; and, Collaborative and "can-do" mindset eager to take on challenges. Functional Experience: Demonstrates knowledge and a proven record of success in or a desire to deliver advisory services in the following capability areas: Experience in the pharmaceutical or medical device industry and/or top consulting firms with a focus on Pharma/Life Sciences.
Senior Director, Quality Management Systems & Compliance Intellia TherapeuticsSenior Director, Quality Management Systems & ComplianceCambridge, MARemote$251,771–$307,721 / yearThe role requires setting strategic direction, leading cross-functional partnerships, maturing the quality management system and digital compliance footprint to support commercialization and managing a high performing team of quality professionals. The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs.
Associate Director, Quality Control (56861) Praxis Precision MedicinesAssociate Director, Quality Control (56861)Boston, MAPraxis is seeking a highly experienced, motivated, and innovative quality leader with strong experience in late-stage development and commercialization to join our Quality team as Associate Director, Quality Control to support QC product release and stability activities. Reporting to Senior Director, Quality Operations CMC, this position will be responsible for managing and executing Quality Control activities in support of product testing, release, and stability, and toxicology studies test material inventory support.
Director, Clinical Quality Assurance Seaport TherapeuticsDirector, Clinical Quality AssuranceBoston, Massachusetts$198,000–$225,000 / yearThe ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a “we own it” mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. Seaport Therapeutics is seeking an experienced Director, Clinical Quality Assurance to manage clinical quality activities supporting clinical development programs, ensuring compliance with regulatory requirements and company policies.
Associate Director, Gcp/Glp/Gvp QA Rhythm PharmaceuticalsAssociate Director, Gcp/Glp/Gvp QABoston, MA$160,000–$240,000 / yearLead or assist with GCP health authority inspections, assist clinical teams in preparation for inspections, and provide GCP compliance technical support during inspections of vendors, clinical investigator sites and Rhythm. Manage Rhythm's QMS for Clinical QA activities, including development and management of controlled documents and training matrices, audits, CAPAs/deviations and management and approval of related documentation.
Associate Director, GCP/GLP/GVP QA Rhythm PharmaceuticalsAssociate Director, GCP/GLP/GVP QABoston, MAFull timeLead or assist with GCP health authority inspections, assist clinical teams in preparation for inspections, and provide GCP compliance technical support during inspections of vendors, clinical investigator sites and Rhythm. Manage Rhythm’s QMS for Clinical QA activities, including development and management of controlled documents and training matrices, audits, CAPAs/deviations and management and approval of related documentation.
Director, Head of Quality Operations 3316 Takeda Development Center AmericasDirector, Head of Quality OperationsBoston, MassachusettsThe actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. You will partner closely with the Head of CPMQ and the CPMQ Leadership Team to drive strategy execution, organizational effectiveness, operational excellence, and business performance across a global organization.
Sr. Director Global Quality Control Scholar Rock Holding CorpSr. Director Global Quality ControlCambridge, MA$245,000–$335,000 / yearProvide strategic oversight of stability programs, including protocol design, pull schedule governance, data review, and trending, shelf-life support, comparability assessments, and post-approval stability commitments. Lead the companys global QC function across a fully outsourced model with end-to-end oversight of external QC laboratories, CMOs, and other testing partners supporting clinical and commercial programs.
Associate Director, Quality Compliance Genetix Biotherapeutics IncAssociate Director, Quality ComplianceSomerville, MA$144,000–$195,000 / yearThe Associate Director, Quality Compliance is a key member of the QA Compliance organization, responsible for ensuring quality oversight of regulatory submissions and lifecycle management for Genetix Biotherapeutics (GTX) products. Additionally, the Associate Director partners cross-functionally and with external vendors to support health authority inspection readiness activities, mock inspections and internal audits.
Senior Director, Corporate Quality - PV Sarepta Therapeutics Inc.Senior Director, Corporate Quality - PVBedford, MA$222,400–$278,000 / yearThis position will liaise with internal groups such as Pharmacovigilance Operations, Safety Evaluation & Risk Management, and Market Research, as well as external groups including contract auditors in an effort to ensure a high level of quality and consistency across the Sarepta platform; design and oversee the audit strategy; assist the GVP team in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance. Primary responsibilities include: Participate in the development of the internal and external Corporate Quality annual audit plan for GVP, REMS, PV vendors, interfaces, processes and preferred business partners and update the audit plan as needed based on identified risks and priorities.
Director, Quality Electric Hydrogen CoDirector, QualityMA$192,270–$226,200 / yearOperationalize and continuously improve core quality processes, including Non-Conformance Reporting (NCR), Incoming Quality Control (IQC), Material Review Board (MRB), and Corrective and Preventive Actions (CAPA). Professional certifications such as ASQ CQE, CQA, CMQ/OE, Lean Six Sigma Black Belt, ISO Lead Auditor, or equivalent quality certifications strongly preferred.
Payer Quality Consultant, Director PricewaterhouseCoopers LLPPayer Quality Consultant, DirectorBoston, MA$155,000–$410,000 / yearPreference for at least one of the following fields of study: Accounting, Actuarial Science, Analytics/Data Science, Business Administration/Management, Computer Science/Information Systems, Economics, Engineering, Finance, Government/Public Policy, Health Administration/Public Health, Mathematics/Statistics, Operations/Supply Chain, Organizational Management/Behavior, Risk Management/Insurance. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy .
Senior Director, Quality Management Systems & Compliance Intellia Therapeutics IncSenior Director, Quality Management Systems & ComplianceCambridge, MARemote$251,771–$307,721 / yearThe role requires setting strategic direction, leading cross-functional partnerships, maturing the quality management system and digital compliance footprint to support commercialization and managing a high performing team of quality professionals. The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs.
Director, Quality Control Editas Medicine, Inc.Director, Quality ControlCambridge, MA$215,000–$235,000 / yearThe successful candidate will collaborate with a high-performing CMC team, coordinating with process and analytical experts cross-functionally in Research and Discovery, Process Development, Analytical Sciences, Manufacturing, and Quality Assurance, to transfer, qualify and oversee in-process and release testing to advance Editas' in vivo gene medicine portfolio. Characterizing Your Impact: As the Director, Quality Control, you will: Lead phase appropriate CMC analytical development, qualification/validation, transfer and optimization through strong collaboration with key stakeholders and external partners.
Associate Director, GMP Quality Formation BioAssociate Director, GMP QualityBoston, MA$161,500–$202,000 / yearRecognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients.
NewDirector, Product Quality WhoopDirector, Product QualityBoston, MassachusettsThis leader will be responsible for ensuring every product launches with exceptional quality through disciplined risk management, robust validation, and scalable quality systems while building the operating mechanisms that govern product quality throughout the product lifecycle: including new product introduction, launch readiness, and post-launch product changes. 15+ years of experience leading Product Quality, NPI Quality, Manufacturing Quality, or Product Engineering organizations supporting high-volume consumer electronics, wearables, consumer products, or similarly complex hardware, including significant people leadership experience.
Senior Director, Analytical Development & Quality Control Rhythm Pharmaceuticals IncSenior Director, Analytical Development & Quality ControlBoston, MA$210,000–$370,000 / yearYou will lead and develop a high-performing organization while overseeing external partners, including CDMOs, CROs, and contract laboratories, to deliver analytical development and QC activities across drug substance and drug product. As the Senior Director, Analytical Development and Quality Control, you will provide strategic and technical leadership for analytical development and quality control across Rhythm's portfolio, spanning discovery through commercialization and lifecycle management.
Director – Quality GCP Monte Rosa Therapeutics, IncDirector – Quality GCPBoston, MassachusettsFull timeOverview: Monte Rosa Therapeutics is seeking a Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities, including GCP quality oversight of ongoing quality activities supporting active pre-clinical and clinical programs through participation on in-house and external cross-functional teams. Responsibilities: Primary GCP Quality contact for identified vendors and investigator sites supporting clinical programs as well as other GCP quality events (e.g., potential serious breach assessments, CAPAs).
Director CMC Quality Compliance (Hybrid) Vertex Pharmaceuticals, IncDirector CMC Quality Compliance (Hybrid)Boston, MA$184,600–$277,000 / yearGeneral Summary: The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external sites including evaluating, improving, and monitoring commercial level quality compliance and quality culture. Responsible for overseeing internal and external sites, working with cross-functional teams to identify areas of compliance risk, and implementing action plans to improve the overall compliance and quality culture of the sites.
Senior Quality Assurance Director Compass Group USA IncSenior Quality Assurance DirectorBoston, MAThis role oversees brand wide food safety programs, supplier controls, operational audits, crisis management, and regulatory compliance across all jurisdictions. The director partners closely with Operations, Supply Chain, Training, and Culinary to ensure safe execution of menu items and consistent guest experience.
NewAssociate Director, Clinical Quality Compliance Stoke Therapeutics IncAssociate Director, Clinical Quality ComplianceBedford, MA$192,000–$215,000 / yearThis person will support Stoke's clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all Stoke clinical and bioanalytical studies. This person will be responsible for establishing Stokes inspections management program for GCP inspections and expected to be influential towards maturing Stoke's quality culture and help reach a sustained state of inspection readiness.
Site Quality Director VulcanFormsSite Quality DirectorDevensAs the Site Quality Director at VulcanForms, your mission is to build and lead the Quality organization for a new, advanced manufacturing facility focused on mass-production, 3D-printed titanium components for a high-volume consumer electronics program. Operating within a fast-paced Business Unit (BU) model, you will directly govern the site’s execution, inspection, and lab infrastructure — rapidly scaling the organization to support maximum facility footprint and full mass-production capacity.
Associate Director, Quality Systems and Compliance Beam Therapeutics IncAssociate Director, Quality Systems and ComplianceCambridge, MA$185,000–$225,000 / yearBeam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. Responsibilities: Qualification: Lead and manage both the onboarding and qualification process for new and existing commercial suppliers (e.g., treatment centers and transportation providers), including pre-classifications and quality system evaluations/reevaluations including identification of quality risks and development of mitigation strategies.
Associate Director, GCP/GLP/GVP QA Rhythm Pharmaceuticals IncAssociate Director, GCP/GLP/GVP QABoston, MA$160,000–$240,000 / yearLead or assist with GCP health authority inspections, assist clinical teams in preparation for inspections, and provide GCP compliance technical support during inspections of vendors, clinical investigator sites and Rhythm. Manage Rhythm's QMS for Clinical QA activities, including development and management of controlled documents and training matrices, audits, CAPAs/deviations and management and approval of related documentation.
Senior Director, Corporate Quality - PV Sarepta Therapeutics IncSenior Director, Corporate Quality - PVBedford, MA$222,400–$278,000 / yearThis position will liaise with internal groups such as Pharmacovigilance Operations, Safety Evaluation & Risk Management, and Market Research, as well as external groups including contract auditors in an effort to ensure a high level of quality and consistency across the Sarepta platform; design and oversee the audit strategy; assist the GVP team in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance. Primary responsibilities include: Participate in the development of the internal and external Corporate Quality annual audit plan for GVP, REMS, PV vendors, interfaces, processes and preferred business partners and update the audit plan as needed based on identified risks and priorities.
Director Of Quality And Regulatory - Transplantation Services And VAD Tufts MedicineDirector Of Quality And Regulatory - Transplantation Services And VADBoston, MA$122,301.82–$155,933.24 / yearMinimum Qualifications: Master's degree in Nursing, Healthcare Administration, Public Health, or a related health science field OR; Bachelor's degree in Nursing, Public Health, or a related field AND Eight (8) years of related experience in quality and regulatory functions within a healthcare setting. A management role that supervises employees focusing on tactical, operational activities within a specified area, with the majority of time spent overseeing area of responsibility, planning, prioritizing and/or directing the responsibilities of employees.
Director, Clinical Program Quality and Excellence 3316 Takeda Development Center AmericasDirector, Clinical Program Quality and ExcellenceBoston, MassachusettsYou will partner closely with global cross-functional stakeholders, including Clinical Development, Study Execution Teams, Regulatory Affairs, and Quality organizations, to identify emerging risks, drive issue resolution, and strengthen quality performance across clinical programs. This role is responsible for shaping and executing risk-based quality management strategies across assigned clinical programs, ensuring inspection readiness, regulatory compliance, and proactive quality oversight throughout the clinical trial lifecycle.