Senior Manager, Quality Assurance
Gilead
Responsibilities
- Serve as global process owner for quality agreement program, ensuring compliance and consistent implementation
- Develop and maintain standardized quality agreement templates, guidance documents, and training materials
- Provide subject matter expertise on quality agreement content, interpretation, and applicability to internal and external stakeholders
- Drive alignment and resolution of complex quality agreement terms across legal, sourcing, and quality teams
- Establish governance processes, metrics, and reporting to ensure program transparency and effectiveness
Requirements
- 8+ years GMP environment experience with bachelor's degree, or 6+ years with master's degree, or 2+ years with PhD/PharmD
- Expertise in quality agreement development, negotiation, lifecycle management, and governance
- Strong knowledge of global regulatory requirements (FDA, EMA, ICH) applicable to quality agreements
- Advanced technical writing skills for drafting and standardizing quality agreement templates
- Cross-functional stakeholder management, influencing, and negotiation capabilities
- Experience managing complex, high-visibility programs with multiple concurrent deliverables
- Preferred experience with contract manufacturing organizations and regulatory authority interactions
Vacancy posted 6 days ago
Similar jobs that could be interesting for youBased on the Senior Manager, Quality Assurance in Foster, CA vacancy
$157.59k - $203.94k
...confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Quality Assurance at Gilead you will report to the Associate Director, Quality Assurance within the PDM External Quality organization....SeniorFull timeContract workFor contractorsLocal areaGILEAD Sciences
Foster, CA4 days ago$163k - $191k
...equality and clarity across communications and decision making.Summary:We are seeking a dedicated and experienced Senior Manager, Clinical Quality Assurance, to join our dynamic team. The ideal candidate will have a strong background in quality management within a...Senior3 days per weekVaxcyte
San Carlos, CA1 day ago$157.59k - $203.94k
...Senior Manager, Quality AssuranceAt Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such... ...for generations to come.As a Senior Manager, Quality Assurance at Gilead you will report to the Associate Director, Quality...SeniorContract workGILEAD
San Mateo, CA13 hours ago$157.59k - $203.94k
...Senior Manager, Quality Assurance At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to...SeniorContract workGILEAD
San Mateo, CA3 days ago- ...Vaxcyte seeks an experienced Senior Manager of Clinical Quality Assurance to lead quality investigations, audits, and compliance activities across clinical development programs. The role requires expertise in regulatory standards, quality management systems, and clinical...Senior
Vaxcyte
San Carlos, CA6 days ago $164k - $205k
...standard of rigor—all in service of patients.The Opportunity:Revolution Medicines is seeking a Senior Manager, Quality Validation who will play a key role within Quality Assurance, providing quality oversight and operational leadership for validation activities across...SeniorFull timeWork at officeLocal areaWorldwideRevolution Medicines
Redwood City, CA13 hours ago- ...Senior Director, Quality As the Senior Director, Quality, you will serve as the quality authority for Sagimet Biosciences, leading and building the company's Quality Management System (QMS) and providing oversight of all Manufacturing Quality activities across the clinical...Senior
Sagimet Biosciences
Foster, CA3 days ago $173.43k - $204.03k
...devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit The Senior Manager of Clinical Quality Assurance (CQA) is a key member of the CQA team and will perform day-to-day clinical quality operations and compliance...SeniorFull time3 days per weekCorcept Therapeutics
Redwood City, CA13 hours ago- Revolution Medicines, a late-stage clinical oncology company, seeks a Senior Manager of Quality Management Systems to lead Quality Event processes, training, and continuous improvement. You will partner across Quality, Manufacturing, Supply Chain, Regulatory, and Safety...Senior
- ...Revolution Medicines seeks a Senior Manager for Quality Validation to oversee validation activities and provide quality assurance leadership across external manufacturing partners supporting commercial oncology products. The role encompasses process qualification, continued...SeniorContract work
Revolution Medicines
Redwood City, CA6 days ago - ...mutations in the RAS signaling pathway. The Opportunity: The Senior Manager, Quality Management Systems (QMS) will support the ongoing... ...Minimum of 10 years of pharmaceutical or biotechnology Quality Assurance or Quality Systems experience. Strong experience with Quality...SeniorContract workTemporary work
- ...Corcept Therapeutics seeks a Senior Manager of Clinical Quality Assurance to lead quality operations and compliance activities supporting clinical studies. The role involves audit planning, GCP audits, risk management, and regulatory oversight in a hybrid position based...Senior
Corcept Therapeutics
Redwood City, CA6 days ago - ...consider all qualified applicants for employment. Position: Senior Manager, Quality Program Management Location: South San Francisco, CA Job... ...is seeking an exceptional candidate to join our Quality Assurance (QA) team. Our ideal candidate is a self-motivated individual...Senior
$230k - $260k
...The Role We are seeking a highly technical and strategic Senior Product Manager with deep AI/ML expertise to lead development across our agentic... ...delivering product experiences that improve the speed, quality, and scalability of data operations. You will work closely...SeniorTemporary workLocal area$213k - $295k
Foster City, CAProgram Management Office - PMO /Full-time /HybridThe Program Management Office (PMO) at Zoox is responsible for driving... ...with upstream teams (e.g. Autonomy, Systems Design & Mission Assurance, Places & Build) and downstream teams (e.g. Data Science, Fleet...SeniorFull timeTemporary workWork at officeImmediate startRelocation packageZoox
San Mateo, CA4 days ago$273k - $290k
...are at a pivotal inflection point.We are looking for a Senior Director of Quality Assurance to build a pragmatic, inspection-ready quality function... ...week or one full week per month.ResponsibilitiesQuality Management SystemOwn the Operating System: Lead the evolution of...SeniorHome officeFlexible hours3 days per weekInsitro
South San Francisco, CA1 day ago- Cytovale, Inc. in South San Francisco, CA is seeking a Head of Quality and Regulatory to own the QMS and serve as the Management Representative. This senior leadership role partners with Regulatory and Operations to drive compliant design, manufacturing, and post-market...Senior
$230.28k - $402.99k
...philosophy and how we use AI in our recruiting process here.The Ads Quality team helps Pinners move from inspiration to action by showing... ...presentation/components (e.g., modules, formats, surfaces) to manage dependencies, define APIs/contracts for your area, align on...SeniorWork at officeLocal areaRelocation packagePinterest
Palo Alto, CA3 days ago- Sr. Project Manager - Quality Management Systems Full-time We are focused on imparting effective business staffing services through high level... ...lead Description: We're seeking a talented, multi-faceted Senior IT Project Manager who is enthusiastic about working in the...SeniorFull time
- ...cancer and autoimmune disease. Led by a management team with significant experience in... ...milestones, we are seeking a Senior Director of Quality Systems and Compliance to shape and lead... ...Manufacturing, Regulatory, and Clinical Quality Assurance to foster a culture of quality and...SeniorFull timeWork at officeLocal areaRemote work2 days per week
Allogene Therapeutics
South San Francisco, CAa month ago - ...applicants for employment. Position Director/Senior Director of Quality Operations Location South San... ...candidate to join our Quality Assurance (QA) team. Our ideal candidate is a self... ...operations through effective quality risk management, supports efficient and reliable...Senior
$136.34k - $176.44k
...Gilead Sciences seeks a Quality Assurance Manager to oversee compliance with regulatory requirements and manufacturing standards. The role involves supervising QA personnel, maintaining GMP/GLP processes, reviewing product quality data, and coordinating investigations...Contract workWork at officeGilead Sciences
Foster, CA6 days ago- ...qualified applicants for employment. Position:Director/Senior Director of Quality Assurance - Medical Device Location: South San Francisco, CA Job Id... ...systems related to the device of the combination product Manage and oversee corrective action teams and develop...SeniorWorldwide
- ...Revolution Medicines seeks a Senior QA Manager to lead GMP/GxP auditing and vendor management for an oncology company. The role oversees internal and external audits, supplier compliance, quality agreements, and regulatory inspection preparation across the organization...Senior
Revolution Medicines
Redwood City, CA6 days ago - Kardigan is seeking a Clinical Quality Lead to drive a culture of quality across R&D, ensuring GxP compliance and consultation on GCP/GLP/GVP guidelines. You will collaborate with cross‑functional teams to evaluate processes, SOPs, and regulatory readiness, and oversee...Senior
$220k - $240k
...our values: care, be real, get it done, and have fun, seriously.POSITION SUMMARYThe Director, GMP Quality Assurance is responsible for the global oversight and management of GMP Quality Assurance operations supporting development and commercial programs.The role manages...Contract workLocal areaMirum Pharmaceuticals
San Mateo, CA13 hours ago$210.38k - $272.25k
...possible, together.Job DescriptionDirector, Global Supplier Quality Management ProgramPosition ImpactThe Director, Global Supplier Quality Management... ...performance measurement systems.Proven ability to influence senior leaders and drive cross-functional alignment in a matrix...Full timeFor contractorsLocal areaGILEAD Sciences
San Mateo, CA3 days ago$95.6k - $195k
...launching our initial commercial service. Overview Quality Control Manager (Inspection Team)Joby Aviation is seeking a Quality Control... ...Inspection teams across manufacturing operations. Reporting to the Senior Manager of Quality Control, this role directs daily quality...Full timeTemporary workShift workJoby Aviation
San Carlos, CA2 days ago$230k - $330k
...Overview Joby Aviation is seeking a Head of Quality to lead our enterprise-wide quality... ...(QC), Quality Engineering (QE), Quality Assurance (QA), Metrology Engineering, and... ...Assurance (QA): Oversee AS9100 Quality Management System (QMS) governance, document control...Full timeTemporary workJoby Aviation
San Carlos, CA1 day ago$260k - $275k
...agonists. We are looking for a Sr. Director, Quality Assurance (QA) to join our South San Francisco... ...Francisco Office. Summary: The Senior Director, Quality Assurance provides... ...-day execution of Vaxart’s GMP quality management systems supporting oral recombinant tablet...SeniorFull timeContract workTemporary workFor contractorsWork at officeShift workVaxart
South San Francisco, CA23 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Manager, Quality Assurance. Be the first to apply!
Related searches
- quality manager Foster, CA
- director quality assurance regulatory affairs Foster, CA
- director of quality Foster, CA
- quality manager healthcare Foster, CA
- corporate quality manager Foster, CA
- director quality management Foster, CA
- senior manager quality engineering Foster, CA
- quality supervisor Foster, CA
- director quality assurance Foster, CA
- quality manager aerospace Foster, CA