Senior QA Manager, GMP GxP Auditing & Vendor Management
New
R
Revolution MedicinesOncology Biotechnology
Remote (United States)Full-TimeManager
Salary150,000 - 189,000 USD per year
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Job Details
- Experience
- Minimum experience required 8+ years of pharmaceutical/Biotech experience with a minimum of 5+ years’ GMP Lead Auditor experience.
Requirements
- BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience.
- Minimum 8+ years of pharmaceutical/Biotech experience.
- Minimum 5+ years of GMP Lead Auditor experience.
- 5 years of QTA and Supplier Quality Management experience.
- ASQ Certified Quality Auditor or equivalent certification.
- Direct experience working with Quality System electronic databases.
- Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word).
- Ability to travel occasionally (up to 25%) to perform external audits.
- Excellent leadership and people management skills.
- Strong written and oral communication and negotiation skills.
Responsibilities
- Lead GxP internal audits and external audits including completing audit reports and follow-up on corrective actions.
- Maintain the internal/external audit schedules and assure GMP/GxP compliance with suppliers.
- Oversight of all aspects of GxP vendor/supplier program management to ensure compliance with GxP regulations and internal standards.
- Collaborate with vendors and internal teams to draft and complete Quality Agreements and perform Risk Assessments.
- Provide support preparation of anticipated regulatory inspections and partner audits with cross-functional teams.
- Maintain supplier management program, ensuring requirements, plans, processes, metrics, and tracking system for GxP suppliers are followed.
- Negotiate, draft, and manage quality technical agreements (QTA) and/or contracts with suppliers.
- Lead supplier performance metrics to monitor system health and drive proactive risk identification.
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