Director, GxP Quality Governance and Partnerships

Revolution Medicines

14d•$201,000 - $251,000•Remote

About The Position

Revolution Medicines is seeking a Director, GxP Quality Governance and Partnerships to provide Quality leadership for establishing and managing Quality Agreements and related arrangements across its expanding global development, manufacturing, and commercial operations. The Director will lead the development, negotiation, implementation, and lifecycle management of agreements across external partners and internal entities, working with cross-functional stakeholders to establish clear responsibilities, appropriate oversight, and alignment with applicable regulatory requirements. The role will help build a scalable approach to Quality governance through standardized agreement practices, defined accountability, effective communication, and oversight of agreed Quality commitments. It will also contribute to broader external partner Quality management and compliance initiatives as the organization grows. This position reports to the Executive Director, GxP Quality and Compliance.

Requirements

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

Nice To Haves

Experience supporting Quality Agreements or external Quality partnerships across multiple GxP disciplines.
Experience working with global partners and regulatory requirements across the US, Europe, Japan, China, Canada, and other markets.
Experience developing or improving agreement management processes, Quality governance frameworks, or external partner oversight programs.
Experience supporting commercial product launches, geographic expansion, or complex business partnerships.
Experience with supplier qualification, audits, or ongoing Quality oversight of external partners.
Experience building scalable processes and programs in a rapidly growing organization.

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 resolution of complex agreement-related issues and negotiations, make timely risk-based decisions, and escalate significant risks or unresolved matters to 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.