Revolution Medicines · 8 hours ago
Senior Director, Quality Control
Redwood City, California, United States
Full-time
Hybrid
Director/Executive
$244K/yr - $305K/yr
12+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The role of Senior Director, Quality Control involves managing clinical and commercial Quality Control activities and leading the QC team to ensure compliance and support for the company's pipeline development.
Health CareLife ScienceMedical
Responsibilities
Playing a critical role as the QC group leader and QC subject matter expert (SME) within Analytical Development (AD) & Quality Control (QC), Pharmaceutical Development and Manufacturing (PDM) department, the position will be responsible for managing clinical and commercial Quality Control (QC) activities from early to late phase development, process validation, commercial launch in support of RevMed’s pipeline development
The candidate will also be responsible for post-approval QC related activities including commercial supplies, lifecycle management, regulatory submissions (e.g., CBE, PAS)
Partner with senior leadership on QC-related strategic development and implement QC policies and practices
Lead the QC team, providing technical and strategic leadership for day-to-day QC activities supporting clinical and commercial programs. Responsibilities include preparation for commercial product launches, management of quality events (e.g., lab investigations for OOS/OOT, deviations, CAPAs)
Direct key QC programs including stability, reference standard, raw material, QC quality systems, procedures, and documentation (e.g., SOPs), PAI readiness, and regulatory inspections
Manage the selection, oversight, and performance management of contract organizations (COs), ensuring the effective outsourcing and execution of clinical and commercial QC activities
Author, review, and approve QC-related documentation, including analytical methods, protocols, reports, and regulatory submissions
Partner with cross-functional teams such as CMC Regulatory Affairs, Drug Substance, Drug Product, Supply Chain, and Quality Assurance to ensure timely achievement of project milestones and objectives
Qualification
Required
BS, MS, or PhD in Chemistry, Pharmaceutical Science, or a related field
12+ years of relevant industry experience in small molecule Analytical Development and Quality Control, with at least 8 years in a senior leadership role
Deep knowledge of global and regional regulatory guidelines (FDA, EMA, ICH, USP etc.), particularly in areas such as method development/validation, process validation, product launches, commercial manufacturing, and post-approval QC requirements
Extensive knowledge and expertise in cGMP compliance and quality control strategies, and industry best practices
Strong analytical and critical thinking skills, with a solid ability to make risk based and data-driven decisions
Excellent scientific, business, and technical communication skills, with strong cross-functional collaboration and strategic planning capabilities
Proven ability to manage multiple priorities and thrive in a fast-paced, dynamic, and innovative environment
Experience with global regulatory submissions, including IND, IMPD, NDA, MAA, and JNDA
Preferred
PhD in Chemistry
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
H1B Sponsorship
Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.25BKey Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M
Leadership Team
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase