Revolution Medicines
Senior Manager, GxP QA Auditor
Revolution Medicines, Redwood City, California, United States, 94061
Quality Assurance Manager
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancer harboring mutations in the RAS signaling pathway. The Opportunity:
The candidate will be responsible for conducting quality audits, vendor compliance with regulations of GxP vendors providing regulated GxP services and products to RevMed. This role is responsible for ensuring compliance with global regulatory requirements, industry standards, and company policies related to supplier oversight. This position will report to the Sr. Dir., Vendor Management and Compliance. Design, develop, and implement an internal/external audit schedule for GxP vendors aligned with RevMed SOPs, and global regulatory requirements. Establish a risk-based process/framework to plan, conduct audits, qualifications, and oversight based on business impact and regulatory requirements. Work with RevMed GxP Quality Heads to oversee the development, implementation, and management of GxP vendors, quality systems procedures, and audits. Review and negotiate Quality Agreements with all major GxP vendors (clinical and commercial). Compile and track quality and compliance metrics (KPI) for GxP vendors and report to management on a quarterly basis. Manage RevMed GxP audits program; develop audits schedule (annually) and conduct internal and external audits. Conduct quality audits of GxP vendors (clinical and commercial) to ensure compliance with RevMed procedures, Quality Agreements, and global regulations. Support partner audits, due diligence activities and regulatory inspections at RevMed GxP Vendors, ensuring inspection readiness and timely resolution of findings. Identify, assess, and mitigate GxP compliance risks including escalation of critical vendor quality events to Sr. management. Collaborate with PDM, GPS, Clinical Development, and other stakeholders to address GxP vendor quality events, and drive continuous improvement. Partner with PDM in selection of GMP vendors including managing the routine qualification activities and monitoring key KPI's. Foster a culture of quality, accountability, and collaboration within the team and across the organization. Stay current with global regulations and provide guidance to quality professional and cross functional teams, and to senior management, as needed. Required Skills, Experience and Education:
Bachelor's degree in life sciences, pharmacy, chemistry, or a related field. Minimum of 10+ years of experience in the pharmaceutical or biotechnology industry, with at least 5+ years' experience conducting audits across clinical and commercial vendors providing GxP services and products. Minimum of 5+ years' experience supporting regulatory inspections (e.g., FDA, EMA, PMDA) in support of BIMO/PAI including conducting mock inspections at GMP establishments. Certified Quality Auditor, CQA (ASQ), ISO lead auditor or equivalent. Strong auditing experience as the lead auditor conducting audits of Contract Manufacturing Organizations, GCP Vendors (i.e., CRO, EDC, TMF and IVRS vendors) Proven record and relevant industry experience in leading supplier quality responsibilities within a global quality organization. Strong understanding and knowledge of global regulations (FDA, EU, HC, ICH Q7, E6), and other applicable regulatory guidelines. Excellent leadership, communication, team building and people skills, with the ability to influence stakeholders at all levels. Analytical thinker with a focus on continuous improvement and innovation. This role may require occasional travel (up to 20%) for quality audits, inspections, and vendor meetings. Flexibility to work in a fast-paced, dynamic environment with evolving priorities. Preferred Skills:
Experience managing/auditing commercial GxP vendors (primarily GMP and GCP), preferably small molecule (DS, SDD, DP and Finished Packaging) vendors, and GCP vendors (CRO, Labs). Regulatory Inspection experience (SME). The base salary range for this full-time position is $158,000 to $198,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. 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 is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancer harboring mutations in the RAS signaling pathway. The Opportunity:
The candidate will be responsible for conducting quality audits, vendor compliance with regulations of GxP vendors providing regulated GxP services and products to RevMed. This role is responsible for ensuring compliance with global regulatory requirements, industry standards, and company policies related to supplier oversight. This position will report to the Sr. Dir., Vendor Management and Compliance. Design, develop, and implement an internal/external audit schedule for GxP vendors aligned with RevMed SOPs, and global regulatory requirements. Establish a risk-based process/framework to plan, conduct audits, qualifications, and oversight based on business impact and regulatory requirements. Work with RevMed GxP Quality Heads to oversee the development, implementation, and management of GxP vendors, quality systems procedures, and audits. Review and negotiate Quality Agreements with all major GxP vendors (clinical and commercial). Compile and track quality and compliance metrics (KPI) for GxP vendors and report to management on a quarterly basis. Manage RevMed GxP audits program; develop audits schedule (annually) and conduct internal and external audits. Conduct quality audits of GxP vendors (clinical and commercial) to ensure compliance with RevMed procedures, Quality Agreements, and global regulations. Support partner audits, due diligence activities and regulatory inspections at RevMed GxP Vendors, ensuring inspection readiness and timely resolution of findings. Identify, assess, and mitigate GxP compliance risks including escalation of critical vendor quality events to Sr. management. Collaborate with PDM, GPS, Clinical Development, and other stakeholders to address GxP vendor quality events, and drive continuous improvement. Partner with PDM in selection of GMP vendors including managing the routine qualification activities and monitoring key KPI's. Foster a culture of quality, accountability, and collaboration within the team and across the organization. Stay current with global regulations and provide guidance to quality professional and cross functional teams, and to senior management, as needed. Required Skills, Experience and Education:
Bachelor's degree in life sciences, pharmacy, chemistry, or a related field. Minimum of 10+ years of experience in the pharmaceutical or biotechnology industry, with at least 5+ years' experience conducting audits across clinical and commercial vendors providing GxP services and products. Minimum of 5+ years' experience supporting regulatory inspections (e.g., FDA, EMA, PMDA) in support of BIMO/PAI including conducting mock inspections at GMP establishments. Certified Quality Auditor, CQA (ASQ), ISO lead auditor or equivalent. Strong auditing experience as the lead auditor conducting audits of Contract Manufacturing Organizations, GCP Vendors (i.e., CRO, EDC, TMF and IVRS vendors) Proven record and relevant industry experience in leading supplier quality responsibilities within a global quality organization. Strong understanding and knowledge of global regulations (FDA, EU, HC, ICH Q7, E6), and other applicable regulatory guidelines. Excellent leadership, communication, team building and people skills, with the ability to influence stakeholders at all levels. Analytical thinker with a focus on continuous improvement and innovation. This role may require occasional travel (up to 20%) for quality audits, inspections, and vendor meetings. Flexibility to work in a fast-paced, dynamic environment with evolving priorities. Preferred Skills:
Experience managing/auditing commercial GxP vendors (primarily GMP and GCP), preferably small molecule (DS, SDD, DP and Finished Packaging) vendors, and GCP vendors (CRO, Labs). Regulatory Inspection experience (SME). The base salary range for this full-time position is $158,000 to $198,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. 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.