Executive Director GMP QA (Good Manufacturing Practice Quality Assurance)

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 scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Executive Director of GMP QA is a senior leadership role responsible for overseeing the quality assurance activities related to Good Manufacturing Practices (GMP) within a global pharmaceutical company. The candidate will ensure compliance with regulatory requirements, industry standards, and company policies for the manufacturing, testing, release and distribution of pharmaceutical products (clinical and commercial). The Executive Director will lead a team of QA professionals, provide strategic leadership, drive continuous improvement initiatives, provide quality oversight of contract organizations and ensure the highest standards of product quality and patient safety. This position will report to the Vice President, Global QA and work from HQ (on-site).  Key responsibilities include:

• Develop and implement the global GMP QA strategy aligned with corporate goals, RevMed SOPs and global regulatory requirements.  

• Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards.  

• Oversee the development, implementation, and maintenance of GMP QA policies, quality agreements, standard operating procedures, and quality systems processes and workflows to manage quality events.

• Manage and oversee all aspects of GxP quality functions for clinical and commercial products i.e., Lot Release, Quality Systems records (i.e., Deviations, Change Control, Complaints, Audits, Product Quality Review).

• Monitor emerging regulatory trends and ensure proactive adaptation of QA processes.  

• Compile, track quality metrics (KPI) on process, product attribute and supplier performance and report to management on a quarterly basis.

• Lead and manage GMP audits programs (internal and external), including manufacturing sites, contract manufacturers and packagers, suppliers, and laboratories.

• Host and support regulatory inspections, ensuring inspection readiness and timely resolution of findings. Represent GMP QA in regulatory inspections, partner audits, and due diligence activities.

• Review and approve audit reports, CAPA plans, and follow-up actions to ensure effective resolution of non-conformance and quality events.

• Lead or oversee the annual product quality review (APQR) process to ensure ongoing evaluation of product quality and compliance.  

• Drive continuous improvement initiatives based on key performance indicators (KPIs), APQR findings and trends.

• Identify, assess, and mitigate GMP-related risks across the supply chain (end to end), GMP vendors and manufacturing processes.

• Provide expert guidance on GMP compliance and escalate critical quality events, nonconformances and compliance issues to cross-functional teams and senior management.

• Collaborate with manufacturing, supply chain, regulatory affairs, and other stakeholders to address quality issues and drive continuous improvement.

• Build, mentor, and lead a high-performing GMP QA team.  Foster a culture of quality, accountability, and collaboration within the team and across the organization.

• Partner with manufacturing, analytical development and quality control, supply chain, regulatory affairs, and R&D to ensure alignment on quality and compliance objectives.

• Support the development and review of batch records, specifications, test methods, protocols and other critical documents.

• Oversee the selection, qualification and ongoing monitoring of all GMP vendors, including contract manufacturers, suppliers, and testing laboratories.

• Ensure vendor compliance with contractual obligations, quality agreements and regulatory requirements.

Required Skills, Experience and Education:

• Undergraduate degree in life sciences, pharmacy, chemistry, or a related field.  

• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with at least 8 years in GMP QA or manufacturing quality roles working in a firm with in-house manufacturing.

• Proven track record and relevant industry experience in leading GMP Q