Senior QA Specialist, Biopharma — GMP & CMO Oversight
Regulatory Toolkit
Cytokinetics, a specialty cardiovascular biopharmaceutical company, is seeking a QA Specialist for Drug Substance. You will perform review of batch documentation for QA certification and oversee documentation for manufacturing, testing, release, and lifecycle management with CMOs and CTLs. You will support the QP function, advise internal/external customers, and provide QA support to cross-functional teams across clinical and commercial programs. #J-18808-Ljbffr Regulatory Toolkit
$140.4k - $163.8k
...Reporting to the Associate Director for QA at Cytokinetics the QA Specialist for Drug Substance will perform... ...certification process. The role involves oversight and review of documentation relating... .... Responsibilities Provide GMP Quality Assurance oversight for clinical...SeniorContract work$280k - $300k
..., seriously.POSITION SUMMARYThe Senior Director, GMP Quality is responsible for the global oversight and management of GMP Quality Assurance... .../RESPONSIBILITIESProvide QA oversight of finished product (FP... ...-party GMP audits, and support CMO pre-approval inspections (PAIs)...SeniorContract workLocal area- Scorpion Therapeutics seeks a Senior Clinical Trial Manager to lead end-to-end management of assigned clinical trials in biopharma, focusing on drug development processes. You will oversee trial operations, manage CRO/vendor relationships, and ensure adherence to GCP,...Senior
- ...Inc. in the South San Francisco and Redwood Shores area is seeking an experienced Senior QA Manager to lead investigations, CAPA, change control, supplier quality, and MRB activities in a GMP cell therapy setting. You will be the on-site QA presence at CDMOs and suppliers...Senior
- ...release and stability testing, and collaborate with the CAR T Research and Process Development groups. This 1-year contract role involves GMP manufacturing support, data integrity, and cross-functional teamwork to drive regulatory-ready #J-18808-Ljbffr Allogene Therapeutics...SeniorContract work
- Denali Therapeutics Inc. is seeking an Associate Director, Healthcare Compliance to oversee FMV payments, Transfer of Value reporting, price transparency, and related audits. The role partners with Finance, IT, Contracts, and Market Access to ensure adherence to HIPAA, ...Senior
$88k - $105k
...What is the role? The Quality Specialist supports Quality Operations through the Quality Oversight of Manufacturing, Packaging, and... ...corrections with Manufacturing, QC, and QA. Ensure identified Quality... ...System (QMS) Support Ensure GMP processes are implemented in the...Contract workTemporary work- ...Position Details Position: Quality Assurance Specialist Location: South San Francisco,CA 94080... ...professional responsible for quality oversight, compliance assessments, internal audits,... ...procedures, and ISO 9001 requirements. Provides QA support for product development, product...Temporary workWorldwideMonday to FridayFlexible hoursShift work
$159k - $207k
...extended characterization activities as well as oversight of control strategy development and... ...for protein therapeutics in the biotech/biopharma industry; or BS/MS with a minimum of 14 years... ..., including familiarity with applicable GMP requirements. In-depth knowledge and...Contract workLocal area$117.9k - $152.57k
...for generations to come. As a Senior Associate Scientist, you will... ...in External Quality Analytical Oversight role supports external... ...Partner with QC Leads, CTLs, and QA to resolve data discrepancies,... ...environment.Working knowledge of GMP principles, data integrity expectation...SeniorFull timeContract workFor contractorsLocal areaShift work$94k - $174.6k
...The Opportunity We are looking for a highly impactful Senior Quality Compliance Specialist with broad experience, a robust risk-based operational... ...leadership toward resolving compliance issues. Provide oversight of core quality systems to ensure consistent compliance...SeniorLocal areaRelocation package$130k - $170k
...second century. Job Description Summary: The Senior Maintenance Supervisor is responsible for... ...Projects Lead and/or provide maintenance oversight for capital projects, equipment... ...maintenance activities comply with food safety, GMP, food security, environmental, electrical...SeniorPermanent employmentFor contractorsLocal areaShift work$177k - $235k
...breakthroughs. Position Description:We are seeking an innovative Senior Scientist / Principal Scientist to bridge the gap between... ...experience in antibody/protein engineering within the biotech or biopharma industryDemonstrated ability to work closely with data scientists...Senior$170.2k - $316k
...transforming society.The Opportunity:As the Senior Principal Product Leader for AI & Lab... ...autonomous execution with scientific oversight and validated laboratory protocols.Who you... ...software engineering, wet lab scientists, AI specialists, and operations).You exhibit exceptional...SeniorLocal areaRelocation package3 days per week- Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier using its TransportVehicle platform. The role leads complex biomarker research programs and cross-functional teams to generate clinical...Senior
- ...oversees staff, vendors, and study execution while ensuring GLP/GCP compliance and timely results. The ideal candidate has 9+ years in biopharma development operations, with strong leadership and vendor management experience within a matrixed organization. #J-18808-Ljbffr...Senior
- Nurix Therapeutics seeks an experienced Senior Scientist to lead analytical method development and lifecycle management for drug product... ...work with ASDs and lipid-based systems. The role includes oversight of CDMO activities and contribution to regulatory submissions....Senior
- Sutro Biopharma, Inc. in South San Francisco, CA, is seeking a Senior Biostatistician to provide hands-on biostatistical support for early- and late-stage clinical studies and related programming. You will design analyses, review results, and collaborate with cross-functional...Senior
- ...Senior Medical DirectorSouth San Francisco, California, United StatesMedical Director... ...Content: Author and provide expert medical oversight for protocols, Investigator Brochures (... ...tier academic research setting.Early Phase Specialist: You possess direct experience or a deep...Senior
$181.62k - $211.89k
...functional team environment. Job Purpose The Senior Manager CMC Quality Control is responsible for the execution and oversight of analytical development and quality control... ...and quality control activities in a GMP environment. Responsibilities Serve...SeniorFull timeContract workWork experience placement- Kamau Therapeutics, Inc. is seeking a Senior Manager / Associate Director, Supply Chain in South San Francisco/Redwood Shores, CA onsite. The role leads sourcing, contracting, and securing critical GMP materials for the clinical manufacturing program, coordinating with...Senior
$150k - $200k
...designing and troubleshooting studies, interpreting tissue-based data, and serving as a technical resource for both internal teams and biopharma customers. This is not a traditional people-management position. The Principal Scientist will lead through scientific expertise,...SeniorPermanent employmentFull time- ...plan analytical development and method qualification for biologics programs. As the primary contact, you will provide analytical oversight at CDMOs to support on-time delivery of clinical materials, manage stability and investigations, and guide #J-18808-Ljbffr Soleil...Senior
- ...to collaborate with the General Manager to plan and oversee the daily business operations. This role is responsible for the direct oversight of all aspects of the business in accordance with Company objectives, including the maximization of financial performance,...Senior
- ...methods (HPLC/SFC), and coordination with cross-functional teams. The successful candidate will drive method development, validation, and CRO oversight while integrating new analytical technologies to advance pipeline goals on site five days a week. #J-18808-Ljbffr BioSpaceSenior
- Motion Recruitment seeks a Sr. Operations Manager for Content Excellence in San Francisco (Hybrid) to oversee the CMO's content operations during a maternity leave. This role shapes strategic planning, content supply chains, and ensures high-quality execution across marketing...Senior
- ...team in the US and Shanghai to conduct trials in a timely fashion while complying with SOPs, ICH/GCP, and country-specific regulatory guidelines. This role requires proactive issue management and strong operational oversight. #J-18808-Ljbffr Structure Therapeutics Inc.Senior
- ...programs. You will partner with study teams, provide expert guidance on GCP/GVP compliance, and ensure ongoing quality oversight of risk tracking and QA processes. With a strong background in ICH E6, QbD, RBQM and QMS, you will drive inspection readiness, support...Senior
- ...balance. About the Position This full‑time, represented Senior Air Quality Specialist role belongs to the Meteorology Measurement Division within... ...up on assignments for timely completion. Provides lead oversight on complex regulatory audits, field investigations, and studies...SeniorFull timeTemporary workWork experience placementLocal area
- Enigma Search in South San Francisco is seeking a Senior Project Manager, Clinical Operations to drive portfolio-level project management... ...-quality trial execution. The role combines study execution oversight with leadership of strategic initiatives such as eTMF...Senior
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