Senior GMP QA Lead, CMC Operations
Proclinical Staffing
Proclinical Staffing is seeking an Associate Director of GMP Quality Assurance to support CMC operations in California. You will lead QA activities for GMP manufacturing, collaborate across cross-functional teams, and ensure regulatory compliance to protect patient safety and supply continuity. The role involves QA oversight of GMP manufacturing and analytical operations, review of documentation, and support for inspections and audits. Travel up to 25% is required. #J-18808-Ljbffr Proclinical Staffing
- Proclinical Staffing in Newark, CA seeks a Specialist/Senior Specialist GMP QA to support CMC operations. The role provides QA oversight of GMP manufacturing, reviews batch records, deviations, and validation data to ensure compliance with FDA, EU, and ICH guidelines....OperationsSenior
$140k - $160k
Specialist/Senior Specialist GMP QA - CMC Operations - Permanent - Newark CAAre you passionate about GMP quality assurance and CMC Operations? Join our... ...request a call back at the top of this page.Proclinical is a leading life sciences recruiter focused on finding exceptional...OperationsSeniorPermanent employmentContract work- Retro is seeking a hands-on Quality Operations lead to own day-to-day QA across programs and ensure robust QMS and compliant clinical manufacturing for aging-therapy programs. You will collaborate with Manufacturing, MSAT, Process Development, QC, and Analytical Development...OperationsSenior
$164k - $205k
...Revolution Medicines is seeking a Senior Manager, GMP Quality who will play a key... ...providing leadership and operational support for RevMed... ...Responsibilities:Serve as the QA lead for commercial finished product... ...Development & Manufacturing (PDM/CMC), Supply Chain, Regulatory...OperationsSeniorFull timeContract workLocal area$200k - $225k
AD GMP QA, CMC Operations - Permanent - Newark, CaliforniaLead quality with confidence-shape the future of innovative therapies while ensuring... ...continuity. Primary Responsibilities:The successful candidate will lead and manage quality assurance activities related to GMP...OperationsPermanent employment- Alamarbiosciences seeks a highly skilled Sr. QC Scientist I for the Operations team, starting with a 6-month onboarding in Product Development. After training on the NULISAseq platform, you will lead QC, troubleshooting, and batch release for antibody pools, ensuring high...OperationsSenior
- ...Biosciences is seeking a highly motivated Quality Control Senior Analyst to join our Operations team. You will support all product testing from raw... ...method transfers, deviations, and documentation. You will lead investigations on QC failures and drive process improvements...OperationsSenior
$175k - $225k
...Associate Director, Quality Assurance - CMC Operations Location: Newark, CAJob... ...Assurance role will be responsible for leading and managing QA activities, oversight, and support to Protagonist’s CMC team with GMP manufacturing. This individual will provide...OperationsFull timeTemporary workWork at officeFlexible hours$155k - $180k
...individual to join us as a Senior Manager, External... ...external manufacturing operations, with a focus on gene-editing... ...and monitor KPIs. Lead continuous improvement... ...years of directly related GMP pharmaceutical... ...preferred.Experience with CMC regulatory submissions...OperationsSeniorFull timeContract workLocal area- Position: Director / Senior Director, Lirentelimab CMC Team Leader Location: Redwood City, CA Job Id: 27... ...Leader reports to the SVP, Technical Operations and is accountable for the AK002 (... ...these critical activities. Your Role: Lead a cross-functional CMC team with...OperationsSenior
$191k - $202k
...to join Aspect’s technical operations team. Reporting to the Chief... ...establishing, scaling, and leading the Quality Assurance (QA) team and directing overall... ...a phase-appropriate, GMP compliant Quality Management... ...reviewing, and approving Quality/CMC sections for regulatory...OperationsLocal area$155k - $200k
A leading biologics CDMO in Fremont seeks a Quality Control Leader to oversee operations, ensuring compliance and high standards in laboratory work. Ideal candidates will have... ...6 years of experience, including 3 years in GMP environments, and must demonstrate strong analytical...OperationsSenior$105k - $130k
Air Liquide USA LLC in Fremont, CA is seeking a Quality Operations Supervisor to manage quality assurance and control initiatives. The... ...implementing internal processes to meet quality requirements, and leading investigations into quality incidents. The ideal candidate...Operations- Bionova Scientific LLC in Fremont, CA seeks a Senior Manufacturing Associate - Upstream to independently execute complex upstream unit operations, mentor junior staff, and lead investigations. The role requires GMP qualification and strong documentation discipline. The...OperationsSeniorFull time
- Position Title: Senior NPI EngineerReporting to: Maya Garcia (Sr.... ...focus on our customers and on operational excellence. With nearly 6,000... ...Engineer is responsible for leading the transition of new medical... ...methodologiesSolid knowledge of GMP, 21 CFR 820 and ISO 13485...OperationsSeniorContract workWorldwide
- Ultimate Staffing seeks a highly motivated Test Supervisor to lead RF and microwave testing operations in a fast-paced manufacturing environment. You will manage a team of test technicians and engineers, ensure safety and testing procedures, and provide technical guidance...OperationsSenior
$180k - $230k
...This hands-on leader will oversee daily QA operations, ensuring compliance and operational excellence... ...include managing quality systems, leading deviation investigations, and... .... Candidates should have 8-12+ years of GMP experience and a scientific degree. Compensation...OperationsSeniorContract work- ..., a subsidiary of Asahi Kasei, seeks a QC Senior Specialist/Scientist to provide advanced analytical... ...-on lab support in Fremont, CA. You will lead assay work (ELISA, qPCR), mentor analysts,... ...contribute to compliant QC processes in a GMP setting. The role requires 5-7 years...Senior
$244k - $282k
...manufacturing, supply chain, and technical operations activities. This role will lead the drafting, negotiation, and... ..., a strong understanding of GMP and regulatory considerations, and the... ...Operations, Quality, Supply Chain, CMC, Finance, and Procurement teams to structure...OperationsSeniorFull timeContract workLocal area- ...Analytical Development and Quality Control. This role involves providing technical leadership for methods development and oversight of CMC activities. Candidates must have over 15 years of experience in pharmaceutical development, including 5 years in CMC leadership. The...Senior
- ...Biotechnologies, Inc. seeks a Director of QA Systems to optimize quality systems across CMC, Clinical, Regulatory and IT. You will lead strategic initiatives, ensure GMP alignment and seamless... ...regulatory knowledge, and the ability to operate in a fast-paced, small company...
$90k - $100k
...and energetic Quality Control Senior Analyst to join a dynamic team of professionals in the Operations team to support the company mission... ...in compliance with ISO 13485/GMP requirements. Key... .... Provide technical input and lead investigation and nonconformance...OperationsSeniorFull timeShift work$150k - $165k
...quality-driven Sr. QC Scientist I to join our Operations team in a role that begins with an... ...records in compliance with ISO 13485 and/or GMP quality standards. Collaborate with Tech... ...based QC data. Experience supporting or leading root cause investigations and CAPA...OperationsSeniorFull time$80 - $90 per hour
...in transitioning processes to GMP‑compliant manufacturing. This... ..., and regulatory compliance. Lead and execute purification development... ...to PD and cross‑functional CMC teams. Support downstream... ...support external manufacturing operations including technical meetings,...OperationsSeniorContract workWork at office$116k - $159.5k
...Cepheid, one of Danaher’s ( 15+ operating companies, our work saves... ...makes everything possible. The Senior Quality Engineer is... ...will have the opportunity to: Lead day-to-day quality engineering... ...of ISO 13485, 21 CFR 820, and GMP requirements. Proven experience...OperationsSeniorImmediate startFlexible hours- ...instrument qualification and change control. Operate and maintain (as well as overseeing the... ...is a plus. Experience working in a GMP setting is preferred. Knowledge of SoftmaxPro... ...developing, producing, and distributing industry‑leading, differentiated products across...OperationsSeniorContract workFor contractorsLocal area
$134.5k - $193.5k
Senior Staff Engineer — Operational ExcellenceLocation: Fremont, CA (on-site)Role Level: Senior Staff EngineerAbout the RoleBloom is seeking a Senior... ...best practices while mentoring and developing engineers. Lead complex cross-functional projects that improve safety, quality...OperationsSeniorFull time- ...for service impact, and collaborate with Design Engineering and Field Operations to improve serviceability. The role requires 5+ years automotive experience, strong communication, and ability to lead cross‑functional programs in a fast-paced environment. On-site role in...OperationsSenior
$244k - $305k
...collaborative, and execution-oriented leader for the role of Senior Director, Global CMC Lead. The Senior Director, Global CMC Lead will provide cross-... ...activities are conducted in compliance with applicable GMP, ICH, FDA, EMA, and other global regulatory requirements.Collaborate...SeniorFull timeLocal area- Work Flexibility: Hybrid or OnsiteStryker is hiring a Senior Staff Clinical Quality Associate for our Neurovascular division. This is... ...clinical processes to ensure clinical services, documentation, and operations align with applicable regulations and quality standards. You...OperationsSeniorFull timeFor contractors
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior GMP QA Lead, CMC Operations. Be the first to apply!
- senior leadership Newark, CA
- senior manager automotive Newark, CA
- senior application administrator Newark, CA
- senior manager accenture Newark, CA
- senior performance engineer Newark, CA
- senior tech Newark, CA
- srs Newark, CA
- senior vice president of operations Newark, CA
- senior manager m&a tax Newark, CA
- senior activities Newark, CA

