Senior Manager, GMP Quality

Revolution Medicines•Redwood City, CA

3d•$164,000 - $205,000•Hybrid

About The Position

Revolution Medicines 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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: Revolution Medicines is seeking a Senior Manager, GMP Quality, who will play a key role within Quality Assurance and is responsible for providing leadership and operational support for RevMed programs through different phases of development, with a strong emphasis on process validation (Drug Substance and Drug Product), and commercial readiness. An individual with a pharmaceutical quality assurance background plays a critical role in GMP Operations and provides quality oversight on GMP production at RevMed’s external vendors in addition to processing of all internal & external GxP documentation at RevMed. This position reports to the Director of GMP Quality.

Requirements

A bachelor’s degree in a scientific or technical discipline is required.
A minimum of 8 years of experience in GMP Quality in the pharmaceutical industry, with experience in late-stage drug product development and validation, is required.
Experience managing quality aspects of development, validation, manufacturing, and testing activities at CMOs, particularly for late-stage DS and DP process validation and commercialization.
Experience in process validation (PPQ), late-stage regulatory submissions, and commercial readiness.
Experience in Inspection Readiness (domestic and ex-US), particularly related to late-stage drug product validation.
Excellent analytical skills and a strong technical background in small molecule process development, validation, and testing are strongly desired.
Knowledge of applicable US and Global compliance regulations and industry practices.
Ability to critically evaluate and troubleshoot complex problems with diligence.
Strong teamwork, collaboration, and management skills.
Ability to manage multiple priorities and aggressive timelines.
Highly responsible, self-motivated professional with enthusiasm and passion for the work.
Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).

Nice To Haves

Hands-on experience working in a manufacturing environment overseeing QA responsibilities for commercial and late-stage programs is preferred.

Responsibilities

Responsible for providing QA oversight of process validation activities.
Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices.
Collaborate with internal and external stakeholders supporting process validation strategies and oversight of PPQ documentation such as Validation Master Plans (VMP), Criticality Analysis (CA), Risk Assessments (RA), Validation Protocols and Reports. Also provide QA oversight to deviation investigations and change controls associated with PPQ activities.
Lead efforts for QA oversight of the manufacture, validation, and disposition of PPQ and commercial product materials, including drug substance (DS), drug product (DP), and final product (FP) at CMOs in partnership with PDM (CMC), Supply Chain, Analytical Development, Quality Control and other functions.
Establish and maintain internal quality metrics for the GMP Quality group that predict the performance and health of the quality systems and processes and effectively communicate compliance-related metrics, risks, and compliance challenges to senior management.
Provide Quality oversight as well as review and approval of CMO documentation and perform product dispositions, as required.
QA lead in periodically reviewing and revising GMP-related SOPs and procedures.
Support quality review of regulatory documents (IND/IMPD, NDA) to ensure compliance with late-stage and commercial drug substance (DS) and drug product (DP) validation requirements.
Participate in inspection readiness efforts, particularly for late-stage development and commercial launch preparations.
Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.