Director, GxP Quality Governance and Partnerships
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:
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Lead the development, review, negotiation, and execution of Quality Agreements and related Quality arrangements supporting clinical development and global commercial operations.
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Manage agreements involving CMOs, CDMOs, contract laboratories, packaging and distribution partners, clinical collaborations, other GxP service providers, and intra-company arrangements.
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Establish clear Quality responsibilities, decision-making authority, oversight expectations, and communication requirements across internal and external partnerships.
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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.
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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.
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Develop and implement a risk-based Quality Agreement lifecycle management framework, including templates, workflows, tracking, periodic reviews, amendments, and renewals.
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Establish effective Quality governance practices for external partnerships, including accountability, communication channels, review mechanisms, and oversight of agreed Quality commitments.
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Partner with operational Quality teams to ensure agreements remain aligned with actual activities, regulatory expectations, and evolving partnership arrangements.
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Support new product launches, geographic expansion, and changes to development and commercial supply networks by establishing appropriate Quality arrangements.
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Identify and implement opportunities to improve processes, cross-functional collaboration, and efficiency in managing external Quality partnerships.
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Contribute to broader external partner Quality oversight, supplier management, and strategic compliance initiatives as organizational needs evolve.
Required Skills, Experience and Education:
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Bachelor’s degree in life sciences, technical, or related field with 12+ years of experience in the biotechnology, pharmaceutical, or medical device industry.
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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:
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Experience supporting Quality Agreements or external Quality partnerships across multiple GxP disciplines.
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Experience working with global partners and regulatory requirements across the US, Europe, Japan, China, Canada, and other markets.
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Experience developing or improving agreement management processes, Quality governance frameworks, or external partner oversight programs.
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Experience supporting commercial product launches, geographic expansion, or complex business partnerships.
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Experience with supplier qualification, audits, or ongoing Quality oversight of external partners.
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Experience building scalable processes and programs in a rapidly growing organization.
#LI-JC1 #LI-Remote
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
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Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
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