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

Real; München; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Real seeks a Senior Laboratory Qualification & Compliance Manager to lead qualification activities for laboratory equipment and systems in a highly regulated GMP environment. The role focuses on lifecycle management, project execution, and continuous improvement across laboratory operations.

You will collaborate with Quality, Laboratory, Engineering and IT, review validation documentation, and drive standardisation of processes while delivering training on qualification topics in German and

Qualifikationen

• Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering or related discipline.
• 6+ years in a regulated GMP environment.
• Strong background in laboratory equipment qualification and compliance.
• Experience with IQ/OQ/PQ and qualification lifecycle activities.
• Knowledge of lab systems such as Empower, LIMS, ELN, CDS, SampleManager, SAP or similar.
• Exposure to CSV, Data Integrity, Annex 11 or 21 CFR Part 11 is advantageous.
• Experience managing docs, deviations, CAPAs and change controls.
• Fluent German and English.

Aufgaben

• Lead qualification activities for laboratory equipment and systems.
• Manage qualification projects from planning through execution and documentation.
• Support procurement, implementation, and lifecycle management of instruments.
• Review and approve qualification and validation documentation.
• Support computerised system qualification and validation activities.
• Drive standardisation and optimisation of qualification processes.
• Manage deviations, change controls and CAPA activities.
• Collaborate with Quality, Laboratory, Engineering and IT stakeholders.
• Deliver training and expert guidance on qualification and compliance topics.

Kenntnisse

GMP compliance

Qualification lifecycle (IQ/OQ/PQ)

Lab equipment qualification

Documentation management

Stakeholder collaboration

Training delivery

German & English language

Ausbildung

Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, 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 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