QMS FDA Manager

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