Director, GxP Quality Governance and Partnerships

Job description

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

The Director, GxP Quality Governance & Partnerships will provide Quality leadership in establishing and managing Quality Agreements and related arrangements supporting Revolution Medicines’ expanding global development, manufacturing, and commercial operations.

The Director will lead the development, negotiation, implementation, and lifecycle management of Quality Agreements across a diverse network of external partners and internal entities. Working closely with Quality, Legal, Development, Manufacturing, Supply Chain, Strategic Sourcing, CMC Regulatory, and external partners, the role will establish clear responsibilities, appropriate oversight, and alignment with applicable regulatory requirements.

The position will also help build a scalable approach to Quality governance, including standardized agreement practices, defined accountability, effective communication, and oversight of agreed Quality commitments. As the organization grows, the role offers opportunities to contribute to broader external partner Quality management and compliance initiatives.

This position reports to the Executive Director, GxP Quality and Compliance.

Responsibilities:

•
Lead the development, review, negotiation, and execution of Quality Agreements and related Quality arrangements supporting clinical development and global commercial operations.

•
Manage agreements involving CMOs, CDMOs, contract laboratories, packaging and distribution partners, clinical collaborations, other GxP service providers, and intra-company arrangements.

•
Establish clear Quality responsibilities, decision-making authority, oversight expectations, and communication requirements across internal and external partnerships.

•
Collaborate with Legal, Strategic Sourcing, Regulatory Affairs, Supply Chain, Technical Operations, Clinical Operations, and other stakeholders to align Quality Agreements with business contracts, operational needs, and applicable regulatory requirements.

•
Lead the resolution of complex agreement-related issues and negotiations, making timely, risk-based decisions and escalating significant risks or unresolved matters to the appropriate leadership or cross-functional teams.

•
Develop and implement a risk-based Quality Agreement lifecycle management framework, including templates, workflows, tracking, periodic reviews, amendments, and renewals.

•
Establish effective Quality governance practices for external partnerships, including accountability, communication channels, review mechanisms, and oversight of agreed Quality commitments.

•
Partner with operational Quality teams to ensure agreements remain aligned with actual activities, regulatory expectations, and evolving partnership arrangements.

•
Support new product launches, geographic expansion, and changes to development and commercial supply networks by establishing appropriate Quality arrangements.

•
Identify and implement opportunities to improve processes, cross-functional collaboration, and efficiency in managing external Quality partnerships.

•
Contribute to broader external partner Quality oversight, supplier management, and strategic compliance initiatives as organizational needs evolve.

Required Skills, Experience and Education:

•
Bachelor’s degree in life sciences, technical, or related field with 12+ years of experience in the biotechnology, pharmaceutical, or medical device industry.

•
Lead the development, review, negotiation, and execution of Quality Agreements and related Quality arrangements supporting clinical development and global commercial operations.

•
Manage agreements involving CMOs, CDMOs, contract laboratories, packaging and distribution partners, clinical collaborations, other GxP service providers, and intra-company arrangements.

•
Establish clear Quality responsibilities, decision-making authority, oversight expectations, and communication requirements across internal and external partnerships.

•
Collaborate with Quality, Legal, Development, Manufacturing, Supply Chain, Strategic Sourcing, CMC Regulatory, and other stakeholders to align Quality Agreements with business contracts, operational needs, and applica

Prepare for the interview

Nothing collected for this employer yet. The Blind 75 is what technical screens draw from; practise it here, with a coach, in Java or Python.

More at Revolution Medicines

• Associate Director, Data Standards and EDC Programming · Redwood City, California, United States
• Associate Director, Marketing, Lung Patient · Remote (United States)
• Associate Director, Field Reimbursement · Remote (United States)
• Associate Director, Access Strategy and Marketing · Remote (United States)
• Senior Manager, Marketing, Lung Cancer · Remote (United States)
• Associate Director, Marketing · Redwood City, California, United States
• Associate Director, Advanced Analytics & AI Enablement · Redwood City, California, United States
• Associate Director, Omnichannel Analytics · Redwood City, California, United States