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QMS FDA Manager at LeasingTeam in Warsaw, Masovian Voivodeship, PL
Skills
Job Description
LeasingTeam Professional supports Polish and global enterprises in sourcing key talent and in human resources management. The Agency specializes in permanent recruitment for mid- and senior level positions and in white-collar outsourcing. It successfully completes recruitment projects by applying a trademark ASSET® methodology that structures recruiter activities and boosts their effectiveness. We have offices in Warsaw, Katowice, Gdansk and Wroclaw. Professional is part of LeasingTeam Group - Poland"s largest group of exclusively Polish-owned personnel consultancy companies that for the past 21 years has been effectively linking candidates with employers and providing them with a comprehensive range of HR services.
For one of our Clients, we are currently looking for:
Job description:
- Maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 9001 and U.S. FDA requirements
- Ensure QMS compliance across PLP2, including production at the European Flavor House (EFH)
- Prepare for and participate in internal and external audits (ISO 9001, FDA, customer and distributor audits)
- Manage controlled QMS documentation, including creation, updates, and archiving
- Coordinate Management Reviews, quality risk assessments, and continuous improvement initiatives
- Lead and monitor corrective and preventive actions (CAPA) and quality events
- Act as the primary point of contact for QMS-related matters and ensure cross-functional alignment
- Oversee quality training, onboarding, and compliance with Good Documentation Practice (GDP)
- Support implementation and use of digital quality systems (Veeva DMS / eQMS)
- Support supplier qualification and quality compliance processes
Expectations:
- University degree in Quality Management, Engineering, Life Sciences, or a related field
- Experience in similiar position
- Good knowledge of Polish and English (min. B2)
- Strong knowledge of ISO 9001 standards and practical experience with FDA requirements
- Ability to share knowledge
Offer:
- Full-time role with the option of an employment contract or B2B arrangement
- Possibility of hybrid work
- Flexible working time
- Real opportunities for professional growth and skills development
- Comprehensive benefits package
- Opportunity to have an impact on the company’s operations
- Work in a friendly and open-minded environment