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Jobtitel

Senior Laboratory Qualification & Compliance Manager (m/f/d)

Arbeitsmodell

Festanstellung

Startdatum

Flexibles Arbeiten

Nein

Ort

München, Bayern, Deutschland

Gehalt

€75000 - €90000 per annum €

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.

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