Director, GxP Quality Governance and Partnerships

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 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.

Preferred Skills:

• 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.

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