Senior GMP Quality Leader: CMC & CDMO Oversight
Generate Biomedicines
Generate Biomedicines seeks a Senior Director of GMP Quality to build and maintain fit-for-purpose quality systems, overseeing CDMOs and contract labs to ensure regulatory and company requirements are met. This hands-on leader partners with Technical Operations, Regulatory Affairs, Clinical Development, and Supply Chain from development through commercialization. You will drive risk-based quality frameworks, lifecycle management, and quality oversight across CMC, analytical strategies, and #J-18808-Ljbffr Generate Biomedicines
- Scorpion Therapeutics Associate Director, GMP Quality will lead QA activities for GMP release of Clinical Trial Materials and Commercial... ...NDA and commercial launches. Key responsibilities include CMO oversight, QA metrics generation, and collaboration with QP for product...QualitySenior
- Generate:Biomedicines seeks a Senior Director of GMP Quality to build and maintain fit-for-purpose quality systems and provide independent oversight of CDMOs and contract labs. You will work with Technical Operations, Regulatory Affairs, Clinical Development, and Supply...QualitySeniorContract work
- Amylyx Pharmaceuticals is seeking an Associate Director, Quality Operations to oversee GMP quality across drug substance, drug product, and... ...activities with contract partners. The position focuses on QA oversight of manufacturing, testing, labeling, packaging, and distribution...QualitySeniorContract work
$210k - $290k
The Role: The Senior Director, GMP Quality will build/support and maintain fit-for-... ...provide independent quality oversight of contract development and... ...Quality oversight of CMC and analytical strategies,... ...Serve as an enterprise Quality leader and strategic advisor to Technical...QualitySeniorContract workFor contractorsShift work- What You’ll DoThe Senior Quality Assurance Specialist provides quality assurance oversight across CMC development, Quality Control, Analytical... ...as a subject matter expert in GMP quality systems, CMC quality... ...audits, supplier audits, and CDMO audits to assess compliance and...QualitySeniorFull timeContract workImmediate start
$173k - $285.33k
...Do As a Director/Senior Director, CMC Drug Substance Development... ...as the functional leader for drug substance... ...research, non-GMP production, GMP production... ...development, Quality Assurance, and CMC Regulatory... ...industry. CDMO Strategy and Oversight : Experience setting...QualitySenior- ...transition by leading CMC team as necessary... ...Operations, Quality, and CDMO partners to establish... ...functional teams and senior leadership.This... ...strong downstream leader who can define purification... ...design, study oversight, data review,... ...transfer, and support of GMP manufacturing...QualityFull timeTemporary workLocal areaFlexible hours
$210k - $320k
.... Director / Director of CMC, to lead our advancing portfolio... ...matter expert, this leader will be accountable for... ...Analytical Development and Quality Control.Develop and... ...cell-based assays.External CDMO alliance management experience and oversight preferred.Strong background...QualitySeniorFull time$195k - $330k
...make an impact:Drive end-to-end CMC program management for mid to... ...substance, drug product, analytical, quality, regulatory, and supply chain... ..., and issuesParticipate in CDMO/CRO meetings to monitor status,... ...and CROs, technology transfer, GMP manufacturing, and commercial supply...QualitySenior- ...Director, Medical Review Lead to join the team in Cambridge, MA. This role involves oversight of medical review for Individual Case Safety Reports (ICSRs) to ensure compliance and quality of safety data. The successful candidate will have substantial experience in drug...QualitySeniorRemote jobFlexible hours
- ...Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies... ...responses to RFIs with minimal supervision, driving high-quality submissions and robust compliance. #J-18808-Ljbffr Relay TherapeuticsQualitySenior
$200k - $260k
...We are seeking a Director/Senior Director, GMP Quality Assurance Operations. You will... ...You will provide Quality oversight across master cell bank, working... ..., technology transfer, CDMO selection and management,... ...closure. Partner closely with CMC, Technical Operations,...QualitySeniorContract workTemporary workFlexible hours$122.25k - $176.58k
Job Title: CMC Demand & Supply LeaderLocation: Framingham, MAAbout... ...of the Demand & Supply Leader is to integrate Project Strategy... ...in respect to Regulatory and Quality requirements. This role offers... ...complex and regulated environments (GMP and GCP regulations)Knowledge...QualityFull time$138k - $185k
About This Role As the Senior Manager, CMC Operations, you will... ...essential operational leader within our Early Phase... ...delivered in alignment with quality, cost, and timeline... ...transition into GMP operations. As the primary... ...chain, procurement, and CDMO activities into...QualitySeniorTemporary workLocal area$210k - $320k
...Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency correspondence and... ....Support Quality Assurance in preparing and hosting GMP and pre-approval inspections.Develops and maintains...QualitySeniorFull timeShift work3 days per week1 day per week$195k - $330k
...execution of global regulatory CMC strategies for degrader... ...partnering closely with CMC, Quality, Non-Clinical, and Clinical Development... ...regulatory CMC guidance to senior leadership regarding health authority... ...with and provide regulatory oversight of CDMOs and other external...QualitySenior$210k - $300k
...Biomedicines is seeking a Senior Director,... ..., this leader will shape the future... ...analytical operations, GMP readiness, and... ...across CDMO and contract testing... ...analytical partner to CMC, Process Development, MS&T, Quality, Regulatory,... ..., and hands-on oversight of CDMOs and contract...QualitySeniorContract workShift work$77.25k - $119.48k
A leading pharmaceutical company in Watertown is seeking a Quality Control Analyst. Responsibilities include laboratory maintenance, preparation... ...have a BS/BA in Chemistry/Biochemistry and 3-8 years of GMP experience. The role offers a competitive salary range from $77,...QualitySenior- ...critical in helping our teams accelerate Progress. Join our CMC dossier Sciences team as CMC dossier leader and you’ll contribute to the CMC development of... ...in pharmaceutical development. Knowledge of digital quality management systems and electronic batch records. Why...Quality
- Amylyx Pharmaceuticals is seeking an Associate Director, CMC Program Management in Cambridge, MA. This role leads cross-functional program management across CMC, aligning regulatory, quality, analytical development, supply chain, and manufacturing to deliver integrated...QualitySenior
$310k - $400k
...subject matter expert, this leader will be accountable for... ...Development and Quality Control. - Develop and implement... ...challenges. - Work closely with CMC and cross-functional sub... ...assays. - External CDMO alliance management experience and oversight preferred. - Strong...QualitySeniorFull time$160k - $200k
...Associate Director, GMP Quality Assurance Operations to be a key leader within the Quality... ...Quality Operations oversight for GMP manufacturing... ...manufacturing at CDMO’s for late-phase programs... ....Reporting to the Senior Director, Quality.... ...closely with CMC, Technical Operations...QualityWork at officeRemote work$202.5k - $337.5k
Global CMC Automation and Robotics Leader 2 weeks ago Be among the first 25 applicants This range is provided... ...wellbeing benefits including high‑quality healthcare, prevention and wellness... ...Discover Extraordinary - together. Seniority Level Director Employment Type Full...QualityFull timeLocal area- Masis Professional Group is seeking a Food Safety & Quality Assurance Manager to lead a FSQA team and drive continuous improvement in food safety programs across operations. The role emphasizes USDA and GFSI standards, strong leadership, and cross-functional collaboration...QualitySeniorHourly payTemporary work
- Philips is seeking a Supplier Quality Engineering Leader for Ultrasound to define and execute the supplier quality strategy across the business. You will ensure regulatory compliance, drive supplier performance, and lead cross-functional collaboration with engineering...QualitySenior
- ...discovery and clinical development. You will design fit-for-purpose assay strategies, drive operations, mentor scientists, and collaborate with Translational Medicine, Data Science, and external partners to deliver high-quality translational data. #J-18808-Ljbffr NovartisQualitySenior
- ...statistics on global drug development teams. The role supports regulatory submissions, study protocols, SAPs and CSRs with a focus on quality, timeliness, and cost-effectiveness. The candidate will drive compound-level analysis, supervise statisticians, and stay current...QualitySeniorRemote job
$135k - $215k
...Opportunity OverviewAs a Senior Manager, Drug Substance you will provide oversight of project teams at CDMO’s working on... ...early and late-stage GMP clinical studies.Collaborate... ...understanding of how CMC integrates and... ...functional areas such as Quality, Preclinical, Clinical...QualitySeniorContract workWork at office- Philips is seeking a Supplier Quality Engineering Leader for Ultrasound to drive supplier quality strategy, ensure regulatory compliance, and lead cross-functional collaboration across SQE, engineering, and procurement. The role requires 10+ years in quality or related...QualitySeniorWork at office
- Ipsen Biopharmaceuticals, Inc. in the United States seeks a Senior Manager of Medical Communications and Publications to lead local neurology... ...global teams to ensure strategic alignment and high scientific quality. The role requires 8+ years in medical communications or...QualitySeniorLocal area
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