Senior Manager, Quality Assurance
Gilead Sciences
August 17, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Job Responsibilities:
- Serve as the Global Process Owner (GPO) for Gilead’s Global Quality Agreement Program, ensuring compliance, consistency, and effective implementation.
- Develop, maintain, and continuously improve standardized Quality Agreement templates, guidance documents, training materials, and related tools.
- Act as the primary SME for Quality Agreement content, interpretation, applicability, and lifecycle; support review, negotiation, implementation, enforcement, and periodic review.
- Drive alignment and resolution of complex Quality Agreement terms with Legal, Sourcing, and External Quality stakeholders.
- Establish and maintain governance processes, metrics, and reporting.
- Monitor regulatory trends and proactively update program requirements and templates.
- Provide expert support during inspections and audits (preparation, defense, remediation).
- Lead or contribute to continuous improvement to enhance processes, reduce cycle times, and improve compliance and user experience.
- Support training and knowledge-sharing.
Qualifications/Requirements:
- 8+ years relevant experience in a GMP environment and a BS/BA OR 6+ years and a MA/MS OR 2+ years and a PhD/PharmD.
Preferred Knowledge/Skills:
- Expertise in Quality Agreements (development, negotiation, lifecycle management, governance) in a global GMP environment.
- Working knowledge of global regulatory requirements (e.g., FDA, EMA, ICH) and ability to translate into compliant contract content.
- Strong technical writing; stakeholder management/influencing/negotiation; communication.
- Experience with CMOs/external partners; regulatory authority interactions and inspection support.
- Experience managing global programs/GPO; familiarity with document/contract lifecycle tools; knowledge of Veeva Vault.
Application Instructions:
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.
Benefits:
- Eligible employees may participate in benefit plans; discretionary annual bonus and stock-based long-term incentives may apply; paid time off and company-sponsored medical, dental, vision, and life insurance plans.
- Serve as the Global Process Owner (GPO) for Gilead’s Global Quality Agreement Program, ensuring compliance, consistency, and effective implementation.
- Develop, maintain, and continuously improve standardized Quality Agreement templates, guidance documents, training materials, and related tools.
- Act as the primary SME for Quality Agreement content, interpretation, applicability, and lifecycle; support review, negotiation, implementation, enforcement, and periodic review.
- Drive alignment and resolution of complex Quality Agreement terms with Legal, Sourcing, and External Quality stakeholders.
- Establish and maintain governance processes, metrics, and reporting.
- Monitor regulatory trends and proactively update program requirements and templates.
- Provide expert support during inspections and audits (preparation, defense, remediation).
- Lead or contribute to continuous improvement to enhance processes, reduce cycle times, and improve compliance and user experience.
- Support training and knowledge-sharing.
Qualifications/Requirements:
- 8+ years relevant experience in a GMP environment and a BS/BA OR 6+ years and a MA/MS OR 2+ years and a PhD/PharmD.
Preferred Knowledge/Skills:
- Expertise in Quality Agreements (development, negotiation, lifecycle management, governance) in a global GMP environment.
- Working knowledge of global regulatory requirements (e.g., FDA, EMA, ICH) and ability to translate into compliant contract content.
- Strong technical writing; stakeholder management/influencing/negotiation; communication.
- Experience with CMOs/external partners; regulatory authority interactions and inspection support.
- Experience managing global programs/GPO; familiarity with document/contract lifecycle tools; knowledge of Veeva Vault.
Application Instructions:
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.
Benefits:
- Eligible employees may participate in benefit plans; discretionary annual bonus and stock-based long-term incentives may apply; paid time off and company-sponsored medical, dental, vision, and life insurance plans.