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

Real Staffing Group; München; On-site; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation package

Long-term career development

International & collaborative work env

Job summary

Real Staffing Group is seeking a Senior Laboratory Qualification & Compliance Manager to lead qualification activities in a highly regulated GMP environment in Munich. The role focuses on qualification of lab equipment and systems, lifecycle management and continuous improvement.

The ideal candidate brings 6+ years in GMP laboratories, strong IQ/OQ/PQ experience and proficiency with CSV, Data Integrity and relevant systems (Empower, LIMS, ELN). Fluent German and English are required.

Qualifications

• 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.
• Familiarity with CSV, Data Integrity, Annex 11 or 21 CFR Part 11 is advantageous.
• Experience with documentation, deviations, CAPAs and change controls.
• Fluent German and English language skills.

Responsibilities

• Lead and coordinate qualification activities for laboratory equipment and 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 related to laboratory systems and equipment.
• Collaborate with Quality, Laboratory, Engineering and IT stakeholders.
• Deliver training and expert guidance on qualification and compliance topics.

Skills

GMP experience

Laboratory equipment qualification

IQ/OQ/PQ

CSV & Data Integrity

Documentation management

German & English

Education

Degree in Life Sciences or related field

Tools

Empower

LIMS

ELN

CDS

SampleManager

SAP

Job description

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