REVOLUTION Medicines
Senior Director, Quality Control
REVOLUTION Medicines, Redwood City, California, United States, 94061
Revolution Medicines (RevMed) is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
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, and commercial launch in support of RevMed pipeline development. The candidate will also be responsible for post-approval QC related activities including Lifecyle management regulatory submissions such as CBE, PAS, etc.
Oversee the QC group, provide technical and strategic leadership for day-to-day QC activities supporting clinical and commercial programs. This includes preparing for commercial product launches, managing quality events related to commercial QC testing (e.g., lab investigations for OOS/OOT, deviations, CAPAs).Lead and guide stability program management, quality systems, QC documentation (e.g., SOPs), PAI readiness, and inspections as necessary.Assist in the selection and drive the 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 post-approval regulatory submissions.Collaborate 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.Required Experience, Skills, and Education:
BS, MS, or PhD in Chemistry, Pharmaceutical Science, or a related discipline.15+ years of relevant industry experience in Analytical Development and QC.In-depth knowledge of global and regional regulatory guidelines (FDA, EU, ICH, etc.), particularly in areas such as Quality by Design (QbD), process validation, product launches, commercial manufacturing and post-approval QC requirements.Strong written and verbal communication skills, paired with excellent interpersonal abilities for effective cross-functional collaboration.Extensive knowledge and application of current GMP, coupled with an understanding of best industry practices.Strong problem-solving skills, with a sound ability to make technically driven decisions.Exceptional scientific, business, and technical communication skills, along with strong planning and collaboration capabilities.Proven ability to multi-task and thrive in a fast-paced, innovative environment.Experience and knowledge of global regulatory submissions (e.g., IND, IMPD, NDA, MAA).Preferred Skills:
Proved leadership in team management and strong organizational skills.Experience in commercial launch of a new product and handling commercial OOS/OOT.
The base salary range for this full-time position is $235,000 to $281,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary 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.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
#LI-Hybrid #LI-CT1
The Opportunity:
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, and commercial launch in support of RevMed pipeline development. The candidate will also be responsible for post-approval QC related activities including Lifecyle management regulatory submissions such as CBE, PAS, etc.
Oversee the QC group, provide technical and strategic leadership for day-to-day QC activities supporting clinical and commercial programs. This includes preparing for commercial product launches, managing quality events related to commercial QC testing (e.g., lab investigations for OOS/OOT, deviations, CAPAs).Lead and guide stability program management, quality systems, QC documentation (e.g., SOPs), PAI readiness, and inspections as necessary.Assist in the selection and drive the 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 post-approval regulatory submissions.Collaborate 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.Required Experience, Skills, and Education:
BS, MS, or PhD in Chemistry, Pharmaceutical Science, or a related discipline.15+ years of relevant industry experience in Analytical Development and QC.In-depth knowledge of global and regional regulatory guidelines (FDA, EU, ICH, etc.), particularly in areas such as Quality by Design (QbD), process validation, product launches, commercial manufacturing and post-approval QC requirements.Strong written and verbal communication skills, paired with excellent interpersonal abilities for effective cross-functional collaboration.Extensive knowledge and application of current GMP, coupled with an understanding of best industry practices.Strong problem-solving skills, with a sound ability to make technically driven decisions.Exceptional scientific, business, and technical communication skills, along with strong planning and collaboration capabilities.Proven ability to multi-task and thrive in a fast-paced, innovative environment.Experience and knowledge of global regulatory submissions (e.g., IND, IMPD, NDA, MAA).Preferred Skills:
Proved leadership in team management and strong organizational skills.Experience in commercial launch of a new product and handling commercial OOS/OOT.
The base salary range for this full-time position is $235,000 to $281,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary 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.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
#LI-Hybrid #LI-CT1