Senior Manager, Quality Assurance
Gilead Sciences
July 01, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Senior Manager, Quality Assurance — PDM External Quality (Global Process Owner for Global Quality Agreement Program)
Job Responsibilities:
- Serve as Global Process Owner (GPO) for the Global Quality Agreement Program; ensure it is compliant, consistent, and effectively implemented.
- Develop, maintain, and continuously improve standardized Quality Agreement templates, guidance, training, and tools aligned to global regulatory requirements and internal policies.
- Act as primary SME for Quality Agreement content, interpretation, and applicability; support review, negotiation, implementation, enforcement, and periodic review.
- Drive alignment and resolution of complex Quality Agreement terms with Legal, Sourcing, and External Quality.
- Establish and maintain governance processes, metrics, and reporting.
- Monitor regulatory trends and update requirements/templates.
- Support inspections and audits (preparation, defense, remediation).
- Lead/contribute to continuous improvement (reduce cycle times; improve compliance and user experience).
- Support training and knowledge-sharing.
Qualifications/Requirements:
- 8+ years GMP-related experience with BS/BA OR 6+ years with MA/MS OR 2+ years with PhD/PharmD.
Preferred Knowledge/Skills:
- Expertise in Quality Agreements (development, negotiation, lifecycle management, governance) in global GMP.
- Working knowledge of FDA/EMA/ICH; ability to translate requirements into contract content.
- Strong technical writing; stakeholder management/influencing/negotiation.
- Ability to manage complex, high-visibility programs in a fast-paced, regulated environment.
- Preferred: CMO/external partner management; regulatory interactions/inspection support; global program/GPO experience; digital tools (incl. Veeva Vault); QMS/QDMS experience.
People Leader Accountabilities: Create Inclusion; Develop Talent; Empower Teams.
Compensation/Benefits:
- Salary range: $157,590.00–$203,940.00; may include discretionary bonus, long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions (internal):
- Apply via the Internal Career Opportunities portal in Workday.
Job Responsibilities:
- Serve as Global Process Owner (GPO) for the Global Quality Agreement Program; ensure it is compliant, consistent, and effectively implemented.
- Develop, maintain, and continuously improve standardized Quality Agreement templates, guidance, training, and tools aligned to global regulatory requirements and internal policies.
- Act as primary SME for Quality Agreement content, interpretation, and applicability; support review, negotiation, implementation, enforcement, and periodic review.
- Drive alignment and resolution of complex Quality Agreement terms with Legal, Sourcing, and External Quality.
- Establish and maintain governance processes, metrics, and reporting.
- Monitor regulatory trends and update requirements/templates.
- Support inspections and audits (preparation, defense, remediation).
- Lead/contribute to continuous improvement (reduce cycle times; improve compliance and user experience).
- Support training and knowledge-sharing.
Qualifications/Requirements:
- 8+ years GMP-related experience with BS/BA OR 6+ years with MA/MS OR 2+ years with PhD/PharmD.
Preferred Knowledge/Skills:
- Expertise in Quality Agreements (development, negotiation, lifecycle management, governance) in global GMP.
- Working knowledge of FDA/EMA/ICH; ability to translate requirements into contract content.
- Strong technical writing; stakeholder management/influencing/negotiation.
- Ability to manage complex, high-visibility programs in a fast-paced, regulated environment.
- Preferred: CMO/external partner management; regulatory interactions/inspection support; global program/GPO experience; digital tools (incl. Veeva Vault); QMS/QDMS experience.
People Leader Accountabilities: Create Inclusion; Develop Talent; Empower Teams.
Compensation/Benefits:
- Salary range: $157,590.00–$203,940.00; may include discretionary bonus, long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions (internal):
- Apply via the Internal Career Opportunities portal in Workday.