Senior QA & Compliance Lead GMP/CMC
Anika Corporation
Anika in Bedford, Massachusetts is looking for a Senior Quality Assurance Specialist to provide quality oversight across manufacturing and CMC development. The ideal candidate should have at least 5 years in Quality Assurance within the biotech or pharmaceutical field, with a strong knowledge of GMP regulations. This role involves reviewing GMP documentation and supporting internal audits while driving continuous improvement initiatives. Anika also offers competitive benefits including a discretionary bonus program and a robust 401(k) plan. #J-18808-Ljbffr Anika Corporation
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior QA & Compliance Lead GMP/CMC in Bedford, MA vacancy
- Mariana Oncology is seeking a Senior QA Specialist for Radioligand GMP Manufacturing Operations. The role focuses on ensuring compliance with quality standards in the production of radiopharmaceuticals... ..., supporting QA activities, and leading investigations. The ideal candidate...Senior
- ...Associate Director, Quality Operations to oversee GMP quality across drug substance, drug... ...in development stages. The role ensures compliance with GMP/GDP standards and supervises activities... ...partners. The position focuses on QA oversight of manufacturing, testing, labeling...SeniorContract work
- Anika in Bedford, MA is seeking a Senior Quality Assurance Specialist to provide QA oversight across CMC development, manufacturing, and supply chain. You will serve as a subject matter expert in GMP quality systems, regulatory readiness, and continuous improvement of QMS...Senior
- What You’ll DoThe Senior Quality Assurance Specialist... ...assurance oversight across CMC development, Quality... ...activities, ensuring compliance with global regulatory... ...subject matter expert in GMP quality systems, CMC quality... ..., inclusive of market-leading benefits to meet our...SeniorFull timeContract workImmediate start
- ...development manufacturing processes. You will lead QA activities across production, testing,... ...distribution for non-commercial programs, ensuring compliance with GMP/GDP standards. The role involves authoring and reviewing IND CMC submissions, managing quality systems,...SuggestedRemote job
- Integer Holdings is seeking a Quality Inspector to lead inspections from raw material intake through final assembly, ensuring GMP-compliant quality and documentation. You will identify non-conforming materials and support NCR processes while maintaining Calibrations and...Senior
- Ocular Therapeutix, Inc., headquartered in Bedford, MA, seeks a Senior QA Associate to provide QA oversight across drug product production... ...transfer to commercialization. You’ll ensure QC activities meet GMP/GLP standards and regulatory expectations, focusing on data integrity...Senior
$134.2k - $202.2k
...MassachusettsShift: Department: HC-RD-RCD1 Reg CMC LM Marketed 1Recruiter: Sarah... ...organization.Your Role:The Senior Manager Regulatory CMC (RCMC)... ...Cycle Management programs. Leads and drives global regulatory... ...Business Partner, Legal, or Compliance immediately. The Company will...SeniorLocal areaImmediate startWorldwide$160k - $200k
...experienced Associate Director, GMP Quality Assurance... ...phase-appropriate GMP compliance, effective execution... ....Reporting to the Senior Director, Quality. This... ..., but not limited to):Lead and execute GMP QA activities for development... ...closely with CMC, Technical Operations,...Work at officeRemote work$127k - $172k
...Reimagine Possible”, we are leading the charge toward a... ...disease.DescriptionThe Senior IT Business Analyst,... ...Laboratory Practice) and GMP (Good Manufacturing Practice... ...to Quality Assurance (QA) and Regulatory Affairs... ...systems validation and compliance support of laboratory...SeniorTemporary workSummer workWork at officeLocal area$200k - $260k
...vision is to build a world leading oncology company... ...are seeking a Director/Senior Director, GMP Quality Assurance Operations... ...demand. Lead QA input into CDMO selection... ...Partner closely with CMC, Technical Operations,... ..., DMS, LMS), ensuring compliance with Part 11 / Annex 1...SeniorContract workTemporary workFlexible hours$82.01k - $113.3k
...Watertown, Massachusetts, is looking for a highly motivated Senior Laboratory Operations Associate to support high-throughput laboratory... ...chemicals. This role focuses on operational excellence and compliance in GMP, vivarium, and chemistry labs. The position offers a...Senior$250k - $273k
The Senior Director, Quality Compliance is responsible for providing strategic leadership... ...best practices. This role leads key quality systems including... ...multiple regions.Collaborate with CMC, Regulatory Affairs,... ...Demonstrated leadership experience in GMP, GCP, and/or GLP...SeniorWork at officeRemote work- GlaxoSmithKline is seeking a Senior Director, Early Phase CMC Medicine Research Leader to assure successful CMC delivery across Rx and Vx programs. You will coach, mentor and recruit CMC leaders, guiding projects from C2LO to Phase 3 and coordinating with EDLs, R&D and...Senior
$210k - $320k
...biotechnology company committed to establishing the leading, fully integrated platform for precision... ...and motivated Sr. Director / Director of CMC, to lead our advancing portfolio of in-... ...), ICH guidelines, and phase-appropriate compliance standards.Collaborate closely with...SeniorFull time- Meet Life Sciences is seeking a Senior Manufacturing Associate to support GMP manufacturing with a focus on cell culture processes, operations excellence, and compliance. This hands‑on role requires independence on the third shift, involvement in quality activities, and...SeniorShift work
$160k - $185k
...us on X, LinkedIn and Facebook.Role Summary:The Senior Manager, GMP QA Operations oversees quality activities associated... ...manufacturing organizations (CMOs) and ensures compliance with FDA and global GMP regulations. Leads tactical GMP QA operations supporting manufacturing...SeniorContract workWork experience placementLocal areaFlexible hours- Werfen is seeking a Senior Software Development Engineer in Test to design, develop, and maintain automated test frameworks for our Digital Solutions. You will lead test automation initiatives across the product lifecycle, supporting manual, exploratory, integration, and...Senior
- 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...
- Syner-G is looking for a Senior Process Engineer based in Bedford, Massachusetts. This... ...readiness of these systems, ensuring compliance with GMP standards. The ideal candidate will have... ...in integrating automation solutions and leading cross-functional project teams. This...Senior
- ...at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics...SeniorWork at officeLocal areaRemote work
AbbVie
Waltham, MA24 days ago $188k - $250.7k
Teledyne FLIR is looking for a Senior Director of Quality in Billerica, Massachusetts.... ...quality and reliability for a $500M business, leading a team of over 30 professionals while... ...with government and customer leaders on compliance matters. The ideal candidate will have a...Senior$160k - $175k
...Join to apply for the Sr. QA Manager role at Piper Companies... ...Companies is seeking a Senior Quality Assurance Manager to lead quality assurance efforts... ...is pivotal in ensuring compliance with regulatory standards... ...Senior Manager Manufacturing (CMC) Quality Assurance Senior...SeniorFull timePiper Companies
Chelmsford, MA1 day ago$172k - $192k
...Senior Manager, Quality ControlStoke Therapeutics... ...all aspects of GMP testing and supporting... ...will also lead stability transfers... ...will support Stoke's CMC team with analytical... ...teams towards ensuring compliance with regulations (e... ....Represent QA / QC on project teams...SeniorContract workTemporary workWork at officeStoke Therapeutics
Bedford, MA4 days ago$252k - $269k
...Clinical Quality Assurance Senior Leader provides... ...quality programs to ensure compliance across global clinical... ...an experienced Clinical QA Senior leader who can build... ...and compliance, and leads the Alkermes strategy... ...division and touchpoints with GMP.Audit & Inspection...SeniorContract workWork at officeLocal areaWorldwideFlexible hours3 days per week$154.4k - $242.55k
...Job DescriptionJoin Takeda as a Senior/Principal Scientist, Cell... ...often working independently and leading function teams or projects. Additionally... ..., process development, GMP release and stability testing,... ...on project teams, CMC sub-teams, and cross-functional...SeniorMinimum wageContract workTemporary workLocal area$195k - $330k
...focused on building an industry-leading pipeline of oral small... ...make an impact:Drive end-to-end CMC program management for mid to... ...and CROs, technology transfer, GMP manufacturing, and commercial... ...expectations (FDA, EMA, ICH), GMP/GLP compliance, and inspection readiness....Senior- Senior Scientist, CMC Analytical Development Join to apply for the Senior Scientist, CMC Analytical... ...on ensuring the safety, efficacy, and compliance of radiopharmaceutical products.... ...reliable results. Ensure adherence to GMP, GLP, and radiation safety protocols....SeniorFull time
- ...in Watertown, MA is seeking a Director of Quality to serve as a GMP subject matter expert across manufacturing, stability,... ...distribution activities performed at external suppliers. The role ensures compliance with FDA/EMA/ICH and supports regulatory submissions. You will...
$185k - $209k
...quality systems for Stoke to ensure compliance with US and international... ...-functional groups such as CMC, commercial manufacturing, Regulatory... ...and administering Stokes QMS. Lead QMS changes and process... ...teams, as needed and provide GMP compliance interpretation, consultation...Temporary workFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior QA & Compliance Lead GMP/CMC. Be the first to apply!
Related searches
- senior application security Bedford, MA
- senior Bedford, MA
- senior customer success engineer Bedford, MA
- senior property accountant Bedford, MA
- senior operations technician Bedford, MA
- senior network engineer Bedford, MA
- senior robotics software engineer Bedford, MA
- senior database analyst Bedford, MA
- senior windows systems engineer Bedford, MA
- senior construction accountant Bedford, MA