Associate Director, GMP Quality - Biologics & Devices
Vertex Inc.
Vertex is seeking an Associate Director, GMP Operational Quality Assurance to lead day-to-day quality operations across multiple programs, ensuring decisions align with patient safety, product quality, regulatory expectations, and business continuity. This role partners with Product Quality Leads, MSAT, Regulatory Affairs, and CDMOs, driving risk management, CAPA, deviations investigations, and quality oversight for external drug substance dispositions across development through process #J-18808-Ljbffr Vertex Inc.
$94.6k - $141.8k
Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible... ...candidate will be a key member of the Vertex Biologics and Devices Quality Team, influencing cross-functional alignment...SuggestedFull timeContract workSummer workRemote workFlexible hours2 days per week$156.6k - $234.8k
...Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles...SuggestedFull timeWork experience placementSummer workRemote workFlexible hoursDay shift2 days per week$160k - $200k
Kiniksa is seeking an experienced Associate Director, GMP Quality Assurance Operations to be a key leader within the Quality organization, responsible... ...development.Hands-on experience supporting biologics manufacturing, including drug substance and drug product...SuggestedWork at officeRemote work- Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and commercial products, including QA review of batch records and supplier compliance. This role partners with CMC, Regulatory and Supply Chain, and will be based in SF or...Suggested
$160k - $180k
Associate Director GMP Quality Reporting to the Head of GMP Quality, you will oversee GMP activities related to Olema’s clinical and commercial products, with a focus on the manufacture of small molecule drug substances (Active Pharmaceutical Ingredients). Responsibilities...SuggestedWork experience placementWork at officeFlexible hours- Amylyx Pharmaceuticals, Inc. is seeking an Associate Director, Quality Operations to provide end-to-end quality oversight of clinical and development... ...for non-commercial programs, ensuring compliance with GMP/GDP standards. The role involves authoring and reviewing IND...Remote job
$185k - $225k
...diseases.Position Overview:We are seeking an Associate Director, Quality Control to lead the Beam Massachusetts... ..., scientifically sound, and timely GMP testing while maintaining a continuous... ...in Chemistry, Biochemistry, Molecular Biology, Cell Biology, Analytical Sciences,...Full time$160k - $240k
..., together.Opportunity OverviewAs an Associate Director, Device Development, you will lead the development... ...audits, inspections, and quality system activitiesLeadership, Operations... ...injectable drug-device interfaces and biologics delivery systems preferred Leadership...Work at office$190k - $230k
...Job Description Job Description Associate Director/Director, Technical Quality – Solid Biosciences Charlestown... ...of processes and analytics, CDMO GMP manufacture, CTL testing, and... ...Experience and understanding of Biologics manufacturing processes and analytics...Temporary workRemote workFlexible hours$154.4k - $242.55k
...empower you to shine? Join us as an Associate Director, Separation Sciences, Biologics Analytical Development in our... ...Biologics Analytical Development & Quality Control. Your responsibilities will... ...supporting biologics development, GMP release, and stability testing.Design...Minimum wageWork at officeLocal areaRemote work$172k - $202k
...motivated, resourceful, and enthusiastic quality control lead excited to be a key contributor... ...requests. You will also support CDMO on GMP commercial manufacturing readiness.At... ...critical quality attributes and developing associated limits/specifications.Excellent communication...Work at officeLocal areaRemote work1 day per week$166.4k - $249.6k
...Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC... ...investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and delivering high-quality regulatory submissions, while serving as...Full timeSummer workRemote workFlexible hours2 days per week$153.9k - $230.9k
Job DescriptionGeneral/Position SummaryThe Associate Director - Shift Quality Operationsis an advanced technical resource in the principles and application... ...decisions.Required Education LevelBachelor’s degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences,...Full timeSummer workFlexible hoursShift work$164.5k - $222.5k
Associate Director, Early Development Quality Lead, R&D QAOverview The Early Development Quality Lead is responsible for the strategic quality oversight... ...complianceQualificationsEducated preferably in life sciences (technology, biological science, pharmacy or other health related discipline...Full timeTemporary workWork experience placementLocal areaRemote workFlexible hours- ...LinkedIn and X. We are seeking an experienced Associate Director of Quality Control (QC) to lead QC operations across the company’s biologics pipeline. You will report directly to the... ...overseeing external testing labs in a GMP environment; you will also be responsible...Contract workTemporary workWork at officeFlexible hours
$169.22k - $253k
...time R11173 Position Summary The Associate Director of MSAT (Manufacturing Science &... ...transfer, and commercial manufacturing of biologic drug substances and drug products. This... ...Partner closely with Process Development, Quality Control, Quality Assurance, Regulatory...Full timeContract workTemporary workLocal areaRemote workWorldwideFlexible hours$148k - $222k
## Associate Director, Quality Systems - Cell and Gene Therapies (VCGT)Applylocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition... ...Knowledge/Skills*** Broad and deep expertise in global GMP regulations, guidances, and Quality Management Systems, as...Summer workLocal areaRemote workFlexible hours2 days per week$155k - $214k
About This Role:As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality excellence.... ...advanced degree (MS/PhD) preferred.At least 10 years of GMP and Quality experience, including 5+ years leading QRM and...Full timeTemporary workLocal area$160k - $240k
Job DescriptionGeneral Summary:The Associate Director, Technical Services is accountable for the technical execution of biologics drug substance manufacturing at external manufacturing... ...rapid containment to protect product quality and supplyLead cross-functional...Full timeSummer workRemote workFlexible hoursShift work2 days per week$161.5k - $202k
...faster and more efficiently. About the Position The Digital Quality Associate Director/Director is a critical member of the Quality Governance... ...of data integrity principles (e.g., ALCOA+) and applicable GMP, GCP, and/or GLP regulations as they pertain to data, records...Work at officeLocal area3 days per week$160.6k - $240.8k
Job DescriptionGeneral Summary:The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced quality assurance oversight of clinical... ...metricsOther RequirementsPrior experience with medical device manufacture and transition to clinical studies or Cell...Full timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week- ...Product Review/Product Quality Review and trend... ...combination product and device implementations in asset... ...pharmaceutical industry, with biological product development... ...experience in Quality associated with biopharmaceutical... ...Strategy Development GMP Knowledge Quality...
$172k - $194k
...position is responsible for providing CMC quality oversight of drug substance, drug... ...in various development stages. As the GMP quality expert, this role is accountable... ...contracted partners. We anticipate hiring the Associate Director, Quality Operations in September 2026....Contract workLocal areaRemote work$184k - $253k
...the Head of Global Product Quality for Biologics, you will lead a dynamic team... ...with Biogen’s policies and GMP guidelines. You will facilitate... ...combination product and device implementations in asset strategy... ...of experience in Quality associated with biopharmaceutical/pharmaceutical...Temporary workWork at officeLocal area$160k - $195k
...and follow us on X, LinkedIn and Facebook.Role Summary:The Associate Director, Quality Management Systems is a key member of the quality team responsible... ...environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred) Demonstrated experience with direct ownership...Local area$158k - $200k
Associate Director/Director, GMP QA & Compliance About Climb: Climb Bio is a clinical-stage biotechnology company... ...Associate Director/Director, GMP Quality and Compliance. Reporting to the VP,... ...including design document review and device vendor audits, utilizing consulting...Contract workTemporary workWork at officeLocal area$142.5k - $256.5k
The RoleThe Associate Director, Quality Control Lab Automation Strategy & Digital Integration is responsible for leading the strategy, implementation... ...value. Success in this role requires strong expertise in GMP laboratory automation, digital systems integration,...Permanent employmentFull timeWork at officeWork from home- ...heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent,... ...operations. About the Role: We are seeking a Senior Manager/Associate Director, Quality & Supply Chain Systems to join our team. The Senior...Temporary workWork at office2 days per week
- Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites including evaluating, improving, and monitoring commercial level quality compliance and quality...Full timeSummer workRemote workFlexible hours2 days per week
- Join to apply for the Associate Director, Lab Operations role at Alnylam... ...storing and transferring of biological materials and test articles... ...create and implement high quality standards of good lab practices... ...Director, Quality - GMP/ Med Device Head of Global Real Estate...Full timeTemporary workWork at officeLocal area
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