GMP Compliance Manager (m/f/d)

Contract start: ASAP

End date: August 2026/possible extension

Responsibilities:

• Maintain and deepen GxP compliance culture within Materials Supply Chapter and Materials Management
• Sensitization, coaching and support of SMEs for the topics of GxP compliance and process improvement
• Tracking and expansion of compliance-relevant KPIs and annual targets at MM LT level for compliance
• Processing and support in deviations and carrying out root cause analyses as well as implementing the necessary corrective or preventive measures
• Processing and supporting changes as well as implementing the necessary measures
• Planning, processing and implementation of technical changes within Materials Management
• Planning, processing and implementation of project work in the GMP environment
• Preparation, participation and representation of the department in internal and external audits and inspections
• Recreation, revision and review of GMP documents
• Creation and revision of risk analyses as well as contact person for the area of Materials Management for QRM topics
• New creation and optimization of training courses as well as implementation of training courses in the field of materials management
• GMP-compliant design of new workflows and support of existing ones
• Deviation, CAPA and change management (deviation/UPE and PE management)
• Representation of the department during internal and external inspections

Requirements:

• Degree in life science or engineering and/or training with extensive practical experience in the field of technical processes in the pharmaceutical industry
• Fluent German and English
• At least 3 years of professional experience in the cGMP environment, especially in managing the implementation of cGMP requirements
• Professional experience in the field of Quality Assurance or Quality Control
• First professional experience in the handling and operation of automated systems in chemical or biotechnological development and production
• In-depth knowledge of the process in your own area of responsibility