Senior QA & Compliance Lead — GMP/CMC
Anika
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
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior QA & Compliance Lead — GMP/CMC in Bedford, MA vacancy
- ...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
- Scorpion Therapeutics is seeking a Senior Manager, CMC QA to oversee Product Complaints, Annual Product Quality Review, and Change Control... ...within biopharmaceutical manufacturing, ensuring GxP compliance. The role leads global quality review processes, supports product...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
$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 hoursCrescent Biopharma
Waltham, MA20 days ago- 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
$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$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- ...Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs... ...with minimal supervision, driving high-quality submissions and robust compliance. #J-18808-Ljbffr Relay TherapeuticsSenior
$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- 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...Senior
$137k - $215.27k
...Takeda’s clinical portfolio.The Senior Manager contributes to the team... ...: KEY INTERFACES:Internal: CMC / PharmSci, GCSC, Quality, Finance... ...scenarios, and inventory strategies.Lead development of alternative... ...requirements and ability to incorporate GMP/GDP/GCP considerations into...SeniorMinimum wageContract workLocal area$195k - $330k
...focused on building an industry-leading pipeline of oral small... ...execution of global regulatory CMC strategies for degrader programs... ...strategic regulatory CMC guidance to senior leadership regarding health... ...partners to ensure regulatory compliance and submission readiness.Scale...Senior- Anika in Bedford, MA is seeking a Senior Crosslink Manufacturing Technician to perform routine and non-routine activities for cross-linked... ...COP/CIP, and keep thorough documentation while adhering to GMP. This role requires 4-6 years in a cGMP environment, strong communication...Senior
- Scorpion Therapeutics is seeking a Senior QC Analyst specializing in raw material testing within a GMP-regulated pharmaceutical setting, focused on ophthalmic product... ...and review HPLC, GC, XRPD, and Karl Fischer tests; lead investigations (OOS/OOT); author SOPs and...Senior
- Biogen, Inc. seeks a Senior Manager, CMC Operations to oversee external development and manufacturing from IND-enabling studies through Phase... ...Quality, Supply Chain, and Finance to ensure alignment with GMP operations. You will develop and manage integrated development...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, MA3 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$172k - $192k
...overseeing all aspects of GMP testing and supporting... ...This individual will also lead stability transfers of... ...person will support Stoke's CMC team with analytical... ...teams towards ensuring compliance with regulations (e.g.,... ...regulations. Represent QA / QC on project teams, as...SeniorContract workTemporary workWork at officeStoke Therapeutics
Bedford, MA1 day ago$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$220k - $300k
...Job Summary: Nova Biomedical is seeking a Senior Quality Director , to lead corporate-level quality and compliance activities across Nova Biomedical’s global manufacturing... ...management experience. ~ Working knowledge of GMP is required. ~ Demonstrated ability to apply...SeniorHourly payWork at officeFlexible hoursNova Biomedical
Waltham, MA22 days ago- Senior Audit Associate - HybridPosition OverviewThe Senior Audit Associate will play a crucial... ...audits for our clients, ensuring compliance with regulatory requirements and internal policies. This position involves leading audit engagements, mentoring junior staff,...Senior
$173k - $285.33k
...You'll Do As a Director/Senior Director, CMC Drug Substance Development,... ...you will design, execute, and lead chemical process development... ...partners for process research, non-GMP production, GMP production,... ...: Strong knowledge of GMP compliance, process safety, plant...SeniorEnanta Pharmaceuticals
Watertown, MAa month ago$134k - $213k
Job Title Senior Quality Operations Manager-Advanced Imaging Job Description The Senior... ...CAPA/Nonconformance processes and ensuring compliance with regulatory standards and operational... ...knowledge of products/services, often leads a cooperative effort among project team members...SeniorFull timeWork at officeLocal areaImmediate startWork visaRelocation package3 days per week- ...analytical excellence, and drive phase-appropriate GMP compliance across a growing modality portfolio. Key Responsibilities Build and lead a high-performing QC organization supporting... ...Cross-Functional Collaboration Partner with CMC, Process Development, MSAT, Regulatory, and...
Vivid Resourcing
Cambridge, MA3 days ago $122k - $150k
...experiences to join our team. What You’ll Do The Senior Specialist, GMP Quality Assurance will collaborate internally with QA, RA, and CMC departments. As needed, work with external... ...Service Providers to ensure oversight and compliance. The Senior Specialist will perform review...SeniorLocal areaFlexible hours3 days per week- ...Burlington, MA, is seeking an Accounting Manager, SEC Reporting to lead external financial reporting activities and the monthly/... ...footnotes, and supporting schedules while ensuring Sarbanes‑Oxley compliance under the Director of SEC Reporting and Technical Accounting. The...Senior
- ...seeks a Quality Assurance Manager to oversee quality control, QA/QMS compliance, and regulatory alignment for allograft processing. You will... ...create and update procedures, manage deviations and CAPAs, and lead risk assessments and audits with cross-functional teams. The...Senior
LeMaitre Vascular
Burlington, MA1 day ago - Entegris is seeking a Senior Director, Strategic Marketing for the Advanced Purity Solutions Division. The role leads marketing strategy and execution to support divisional units and sales functions, partnering with divisional leaders to drive growth. The ideal candidate...Senior
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 director product management Bedford, MA
- senior grant accountant Bedford, MA
- senior consulting engineer Bedford, MA
- senior IT support specialist Bedford, MA
- senior security operations engineer Bedford, MA
- sr accountant Bedford, MA
- senior qa Bedford, MA
- senior medical science liaison Bedford, MA
- senior property accountant Bedford, MA
- senior software engineer remote Bedford, MA