Senior QA Manager, GCP GXP Auditor

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.

• Maintain the approved supplier list.

Required Skills, Experience and Education:

• 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.

Preferred Skills:

• 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. 

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