Senior Manager, Quality Assurance
About The Position
The Senior Manager, Quality Assurance reports to the Associate Director, Quality Assurance within the PDM External Quality organization and manages and supports Gilead’s Global Quality Agreement Program. The position serves as the program’s Global Process Owner (GPO), with high visibility across the PDM organization, and collaborates with internal partners and stakeholders to establish and maintain an effective program. The role is the primary subject matter expert for Quality Agreement content, lifecycle management, negotiations, and template management in compliance with applicable laws and regulatory requirements. It also supports continuous improvement initiatives and consistent application of program requirements across internal teams and external partners.
Requirements
- 8+ years of relevant experience in a GMP-environment-related field and a BS or BA; or 6+ years of relevant experience and an MA/MS; or 2+ years of relevant experience and a PhD/PharmD.
- Expertise in Quality Agreements, including development, negotiation, lifecycle management, and governance in a global GMP environment.
- Strong working knowledge of global regulatory requirements applicable to Quality Agreements, such as FDA, EMA, and ICH requirements, and ability to translate them into compliant contract content.
- Strong technical writing skills, including drafting, reviewing, and standardizing Quality Agreement templates and supporting documentation.
- Advanced stakeholder management, influencing, and negotiation skills across cross-functional and external-partner environments.
- Ability to manage and support complex, high-visibility programs with multiple concurrent deliverables and competing priorities.
- Strong communication skills and ability to explain Quality Agreement expectations to internal stakeholders and external partners.
- Ability to learn quickly and work effectively in a fast-paced, highly regulated environment.
Nice To Haves
- Experience working with and managing relationships with Contract Manufacturing Organizations (CMOs) and other external partners.
- Experience interacting with regulatory authorities and supporting inspections related to Quality Agreements or external quality oversight.
- Experience managing global programs or serving as a Global Process Owner (GPO).
- Familiarity with digital tools or systems for document management, contract lifecycle management, or Quality Agreement tracking.
- Experience and working knowledge of digital Quality Management Systems and Quality Document Management Systems, particularly Veeva Vault.
Responsibilities
- Serve as Global Process Owner for Gilead’s Global Quality Agreement Program, ensuring it is compliant, consistent, and effectively implemented across the organization.
- Develop, maintain, and improve standardized Quality Agreement templates, guidance documents, training materials, and related tools to align with global regulatory requirements and internal policies.
- Provide subject-matter expertise on Quality Agreement content, interpretation, and applicability; support internal stakeholders with review, negotiation, implementation, enforcement, and periodic review of agreements.
- Drive alignment and resolution of complex Quality Agreement terms with Legal, Sourcing, and External Quality stakeholders.
- Establish and maintain program governance processes, metrics, and reporting.
- Monitor regulatory trends and evolving expectations and update program requirements and templates accordingly.
- Provide expert support during inspections and audits related to Quality Agreements, including preparation, defense, and remediation.
- Lead or contribute to continuous improvement initiatives to improve processes, reduce cycle times, and enhance compliance and user experience.
- Support training and knowledge-sharing to promote consistent understanding and application of Quality Agreement requirements.
Benefits
- Company-sponsored medical, dental, vision, and life insurance plans.
- Paid time off.
- May be eligible for a discretionary annual bonus.
- May be eligible for discretionary stock-based long-term incentives, depending on role.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
