Senior Manager, Quality Assurance
About The Position
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to 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. This position is dedicated to managing and supporting the Gilead Global Quality Agreement Program. This position will have high visibility throughout the PDM organization as the Global Process Owner (GPO) for Gilead’s Global Quality Agreement Program and will collaborate with key internal partners & stakeholders to establish and maintain an effective Global Quality Agreement Program. This position will serve as the primary subject matter expert (SME) for matters related to Quality Agreement content, Quality Agreement lifecycle management, Quality Agreement negotiations, management of Quality Agreement templates in compliance with applicable laws and regulatory requirements, and supporting continuous improvement initiatives related to the Global Quality Agreement Program.
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
Nice To Haves
- 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
- 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.
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
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
