Senior QA Manager, GCP GXP Auditor

Revolution Medicines•Redwood City, CA

7h•Hybrid

About The Position

The Opportunity: Lead internal audit of GCP systems and relative departments, following up through CAPA implementation. Perform GxP internal audits to applicable regulations including completing audit reports and follow-up on corrective actions. Perform audits of TMFs for various programs. Assure oversight of CROs. Understand the clinical development process and demonstrate capability to manage the internal clinical audit program. Create and maintain the internal GCP annual audit schedule. Demonstrate the ability to multi-task, prioritize work, and independently solve problems. Support external audits as needed. Collaborate with cross-funstional teams and represent Quality Vendor Management at meetings. GxP vendor/supplier program management to ensure compliance with GxP regulations and RevMed internal standards. Perform Risk Assessments as needed. Update SOPS. Create and implement tools to improve compliance, consistency, and efficiency for GCP auditing. Provide support in preparation of anticipated regulatory inspections and partner with cross-functional teams. Maintain supplier management program, enduring requirements, plans, processes, metrics, and tracking systems for GxP suppliers are established and followed. Assure the qualification of GCP/GxP suppliers are being performed and maintained per SOPs and KPIs. Support Quality Agreements and/or contracts with suppliers as needed. Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to RevMed procedures. Lead supplier performance metrics to monitor the health of systems, drive proactive identification of risk and mitigate compliance issues. Update Veeva, track KPIs, and assure GxP audits completed on time.

Requirements

BA/BS degree in Biological Sciences, Chemistry, or related field and /or equivalent experience and education.
Minimum experience required: 10+ years of pharmaceutical/Biotech experience experience with a minimum of 5+ years GCP Auditing experience including having audited TMFs.
Familiar with GCP, GLP regulations in US and EU and ICH requirements.
ASQ Certified Quality Auditor or equivalent certifications.
Excellent leadership and people management /development skills.
Strong written and oral communication skills as well as organizational skills.
Ability to travel occasionally (up to 25%) to support audits.
Ability to navigate through rapid growth and adapt to rapid change.
Direct experience working with Quality System electronic databases.
Proficiency with Microsoft Office (Excel, Outlook, Powerpoint, Work) required.

Nice To Haves

Quality Clinical management experience.
Strategic thinking and project management skills.
Direct experience with handling and /or participating in regulatory body inspections.
Proven ability to develop presentations and analyze complex data.
Experience working with Veeva Quality System Platform.

Responsibilities

Lead internal audit of GCP systems and relative departments, following up through CAPA implementation.
Perform GxP internal audits to applicable regulations including completing audit reports and follow-up on corrective actions.
Perform audits of TMFs for various programs.
Assure oversight of CROs.
Understand the clinical development process and demonstrate capability to manage the internal clinical audit program.
Create and maintain the internal GCP annual audit schedule.
Demonstrate the ability to multi-task, prioritize work, and independently solve problems.
Support external audits as needed.
Collaborate with cross-funstional teams and represent Quality Vendor Management at meetings.
GxP vendor/supplier program management to ensure compliance with GxP regulations and RevMed internal standards.
Perform Risk Assessments as needed.
Update SOPS.
Create and implement tools to improve compliance, consistency, and efficiency for GCP auditing.
Provide support in preparation of anticipated regulatory inspections and partner with cross-functional teams.
Maintain supplier management program, enduring requirements, plans, processes, metrics, and tracking systems for GxP suppliers are established and followed.
Assure the qualification of GCP/GxP suppliers are being performed and maintained per SOPs and KPIs.
Support Quality Agreements and/or contracts with suppliers as needed.
Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to RevMed procedures.
Lead supplier performance metrics to monitor the health of systems, drive proactive identification of risk and mitigate compliance issues.
Update Veeva, track KPIs, and assure GxP audits completed on time.
Maintain the approved supplier list.