Description
Role OverviewThe Senior Manager, Global Quality Assurance is responsible for the Quality Assurance oversight of the activities supporting manufacturing and product release at the Medexus Contract Manufacturing Organizations (CMOs). The manager will ensure that all Active Pharmaceutical Ingredients and Finished Products and processes meet the U.S. FDA, Health Canada, European Medicines Agency (EMA), and ICH (International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use) regulations and guidances for Drugs, Biologics and Medical Devices. This position will lead oversee Product Release activities, Supplier Management, Risk Assessment, CAPA and Change Review Board teams and provide QA review of technical manufacturing documents. The Manufacturing QA position works collaboratively with Medexus Regulatory, Supply Chain, Technical Operations, and Document Control teams.
Key Responsibilities- Manage the Medexus Quality Systems and ensure Medexus harmonization and compliance across all products in the key Quality Assurance activities including:
- Batch Record Review, Batch Disposition and Product Release to market
- Internal Change Control process, Nonconformance Investigation, CAPA, Annual Product Quality Review (APQR), Product Complaint Investigations and Design Control.
- Lead Material Review Board, CAPA Review Board, Change Review Board, and Risk Assessment teams.
- Lead and develop GQA staff, ensuring operational excellence and to ensure effective quality oversight, regulatory compliance, and consistent product supply.
- Build relationships with internal and external partners to ensure compliant quality systems.
- Assist GQA Team with the resolution of quality-related product issues.
- Ensure Quality Assurance approval of Supplier GMP documentation, including Master Batch Records, Test Methods, Specifications and Design Characterization, Verification, and Validation activities.
- Accountable for Internal Audits of GMP activities and External Audits by partners or regulatory authorities.
- Accountable for the track and report quality system metrics to support continuous improvement initiatives
Qualifications and Experience- Bachelor's or Master's degree in science or a related field.
- 15+ years of experience in QA within the pharmaceutical or biotechnology industry. Experience across multiple industries is preferred.
- 8+ years of experience managing and developing direct reports related to Quality or Compliance activities.
- Extensive knowledge of U.S. FDA, Health Canada GxP and EMA regulatory requirements.
- Demonstrated experience leading CAPA and Change Review Boards, internal audits and regulatory audits .
- Advanced proficiency in Microsoft Word, Excel, and PowerPoint
- Familiarity with project management tools such as Monday.com and Smartsheet and data analytics tools such as JMP. (preferred)
Additional Information- Location: Remote position located in US or Canada
- Travel: up to 25%
- Compensation: $140,000 - $180,000
We recognize that experience comes in many forms. Even if your background or compensation expectations don't exactly align with all the qualifications or compensation range listed, we encourage you to apply. Your unique skills and experience may be a great fit for this role or other opportunities at Medexus.
Compensation
$140,000.00 - $180,000.00 per year
