Senior Manager, Quality Assurance

Job Responsibilities

• Serves as the Global Process Owner (GPO) for Gilead's Global Quality Agreement Program, ensuring the program is compliant, consistent, and effectively implemented across the organization
• Develops, maintains, and continuously improves standardized Quality Agreement templates, guidance documents, training materials, and related tools to align with global regulatory requirements and internal policies
• Serves as the primary subject matter expert (SME) for Quality Agreement content, interpretation, and applicability across internal teams and external partners, which may include supporting internal stakeholders during review, negotiation, implementation, enforcement, and periodic review of Quality Agreements
• Drives alignment and resolution of complex Quality Agreement terms through collaboration with Legal, Sourcing, and External Quality stakeholders
• Establishes and maintains governance processes, metrics, and reporting for the Global Quality Agreement Program to ensure transparency and effectiveness
• Monitors regulatory trends and evolving expectations related to Quality Agreements and proactively updates program requirements and templates accordingly
• Provides expert support during inspections and audits related to Quality Agreements, including preparation, defense, and remediation activities
• Leads or contributes to continuous improvement initiatives to enhance Quality Agreement processes, reduce cycle times, and improve compliance and user experience
• Supports training and knowledge-sharing activities to ensure consistent understanding and application of Quality Agreement requirements across the organization

The best candidate...

• Demonstrates expertise in Quality Agreements, including development, negotiation, lifecycle management, and governance in a global GMP environment
• Demonstrates strong working knowledge of global regulatory requirements applicable to Quality Agreements (e.g., FDA, EMA, ICH) and ability to translate requirements into compliant contract content
• Demonstrates strong technical writing skills with the ability to draft, review, and standardize Quality Agreement templates and supporting documentation
• Demonstrates advanced stakeholder management, influencing, and negotiation skills across cross-functional and external partner environments
• Demonstrates ability to manage and support complex, high-visibility programs with multiple concurrent deliverables and competing priorities
• Demonstrates strong communication skills, including the ability to clearly articulate Quality Agreement expectations to internal stakeholders and external partners
• Demonstrates the ability to learn quickly and operate effectively in a fast-paced, highly regulated environment

Requirements

• 8+ years of relevant experience in a GMP environment related field and a BS or BA OR 6+ years of relevant experience in a GMP environment related field and a MA/MS OR 2+ years of relevant experience in a GMP environment related field and a PhD/PharmD

Preferred Knowledge

• Experience working with and managing relationships with Contract Manufacturing Organizations (CMOs) and other external partners is preferred
• Experience interacting with regulatory authorities and supporting inspections related to Quality Agreements or external quality oversight is beneficial and preferred
• Experience managing global programs or serving as a Global Process Owner (GPO) is beneficial
• Familiarity with digital tools or systems supporting document management, contract lifecycle management, or Quality Agreement tracking is beneficial
• Experience and working knowledge with digital Quality Management Systems and Quality Document Management Systems, particularly Veeva Vault, is beneficial