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 controls
- Fluent 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
SThree_Germany is acting as an Employment Agency in relation to this vacancy.