We are currently supporting a global pharmaceutical company in the search for a Senior Laboratory Qualification & Compliance Manager (m/f/d) to join a highly regulated GMP environment.
This position plays a key role in ensuring the qualification, compliance, and lifecycle management of laboratory equipment and systems while supporting continuous improvement across laboratory operations.
Main Responsibilities
- Lead and coordinate qualification activities for laboratory equipment and laboratory systems
- Manage qualification projects from planning through execution and documentation
- Support procurement, implementation, and lifecycle management of laboratory instruments
- Review and approve qualification and validation documentation
- Support computerised system qualification and validation activities
- Drive standardisation and optimisation of qualification processes and procedures
- Manage deviations, change controls and CAPA activities related to laboratory systems and equipment
- Collaborate closely with Quality, Laboratory, Engineering and IT stakeholders
- Deliver training and expert guidance on qualification and compliance topics
Main Requirements
- Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, or a related discipline
- 6+ years of experience within a regulated GMP environment
- Strong background in laboratory equipment qualification and compliance
- Experience with qualification lifecycle activities, including IQ/OQ/PQ
- Knowledge of laboratory systems and applications such as Empower, LIMS, ELN, CDS, SampleManager, SAP or comparable platforms
- Exposure to CSV, Data Integrity, Annex 11 or 21 CFR Part 11 would be advantageous
- Experience managing documentation, deviations, CAPAs and change controlsFluent German and English language skills
What Is Offered
- Opportunity to join a globally recognised pharmaceutical organisation
- High-impact position with broad stakeholder exposure
- Involvement in complex laboratory and quality initiatives
- International and collaborative working environment
- Competitive compensation package
- Long-term career development opportunities
#J-18808-Ljbffr
Senior Laboratory Qualification & Compliance Manager (m/f/d) in München Arbeitgeber: Real Staffing Group
Als innovativer Medizintechnikhersteller im Südwesten Baden-Württembergs bieten wir Ihnen die Möglichkeit, aktiv an der digitalen Transformation und der Gestaltung von Produktlebenszyklen mitzuwirken. Unsere Unternehmenskultur fördert Zusammenarbeit und Kreativität, während wir Ihnen attraktive Vergütung und individuelle Weiterentwicklungsmöglichkeiten bieten. Bei uns finden Sie ein internationales Umfeld mit kurzen Entscheidungswegen, das Ihnen einen hohen Gestaltungsspielraum in Ihrer Rolle als Business Process Engineer ERP (m/w/d) ermöglicht.
