Associate Director, Analytical Development & QC

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins.

About the role

The Associate Director QC will oversee Quality Control testing at contract labs for drug substance, drug product, and stability programs across commercial and development portfolios. This role partners cross-functionally within PDM (drug substance, drug product, CMC Regulatory Affairs) and QA to manage method transfers, validations, and data oversight aligned with development and production timelines. Key responsibilities include vendor oversight, data review, external audits, and management of GMP-related exceptions (e.g., deviations, CAPAs, OOS/OOT, change controls).

Responsibilities

• Lead and/or coordinate QC activities of late phase and commercial programs, including commercial launch readiness, in-process control test, final release test, PAI readiness, and inspection as needed.
• Oversee and manage outsourced commercial QC activities at CDMOs and/or contract testing labs (CTLs).
• Manage quality events related to commercial QC testing such as lab investigations (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0), and CAPAs.
• Author and/or review commercial QC-related documents, including methods, protocols, reports, and memos.
• Manage commercial phase reference materials including monitoring retest dates, facilitating qualification/requalification, and tracking inventory.
• Collaborate with cross-functional teams including CMC RA, DS, DP, Supply Chain, and Quality Assurance to timely achieve project goals.
• Coach, mentor, and engage team to ensure business goals and development plans are met.
• Establish and monitor operational metrics to track performance and identify trends.
• Monitor emerging regulatory requirements and assess organizational impact.
• Lead remediation efforts for identified gaps and drive continuous improvement initiatives.

Requirements

• Bachelor’s degree in a scientific discipline with 15+ years of experience in pharmaceutical QC operations across development and commercial stages. Alternatively, a Master’s degree with 12+ years or a PhD with 10+ years is acceptable.
• Solid understanding of relevant global and regional regulatory guidelines (FDA, EU, ICH, etc.) as applicable to QbD, commercial process validation, commercial product launch, commercial manufacture sampling and testing, and post-approval quality control requirements.
• Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA, MAA, etc.).
• Extensive knowledge and understanding of cGMP guidelines and practices, as well as related/best industry practices.
• Strong problem-solving skills with sound technically driven decision-making ability.

Skills

• Small molecule experience is required; biologics experience is highly preferred.
• Effective written and verbal communication skills and strong interpersonal/collaboration skills.
• Excellent scientific and business communication skills (verbal, written, and technical).
• Ability to think critically and creatively and work independently to resolve problems.
• Ability to multi-task and thrive in a fast-paced innovative environment.

Pay

Base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA: $186,000 - $233,000 USD. The range will be adjusted for the local market a candidate is based in. Individual base pay salary is determined by job-related skills, experience, market dynamics, and relevant education or training.

Benefits

Competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.