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

Real Staffing; München; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Competitive compensation package

Long-term career development

Zusammenfassung

Real Staffing, on behalf of a global pharmaceutical company, seeks a Senior Laboratory Qualification & Compliance Manager (m/f/d) in Munich to join a highly regulated GMP environment.

You will lead qualification activities for laboratory equipment and systems, manage lifecycle projects, and support CSV, change controls and CAPA across QA, IT, and Engineering teams. Fluent German and English are preferred for stakeholder collaboration.

Qualifikationen

• 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.

Aufgaben

• 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 with Quality, Laboratory, Engineering and IT stakeholders.
• Deliver training and expert guidance on qualification and compliance topics.

Kenntnisse

Lab qualification

Compliance management

GMP experience

Ausbildung

Degree in Life Sciences/Pharmacy/Chemistry/Biotech/Engineering

Tools

Empower

LIMS

ELN

CDS

SampleManager

SAP

Jobbeschreibung

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