Menarini - Von Heyden GmH: Teamleiter (m/w/d) Compliance
Core
Lead the Compliance team within Quality Assurance to ensure adherence to regulatory requirements and internal quality standards in pharmaceutical manufacturing.
Role type
Senior Compliance Team Lead (Quality Assurance)
Builds
Pharmaceutical manufacturing processes and quality management systems
Domain
Pharmaceuticals / Quality Assurance / Regulatory Compliance
Required skills
Team leadership, regulatory compliance management, quality process optimization, supplier/manufacturer auditing, GMP knowledge, change control management, stakeholder negotiation, training management, documentation management, risk assessment
Preferred skills
Master's degree in natural sciences or pharmacy, experience in international environments, MS Office proficiency
Technologies
GMP systems, Document Management Systems, MS Office
Responsibilities
Lead and mentor the high-performing Compliance team; Ensure full compliance with regulatory and internal quality standards; Develop and maintain the Quality Management Manual and document management system; Conduct audits of manufacturers and suppliers; Organize and accompany regulatory and customer inspections; Implement GMP training management systems; Manage reporting obligations to authorities; Obtain regulatory documents (e.g., import licenses, GMP certificates); Approve self-inspection protocols and evaluate change control requests; Maintain GMP culture through presence in production areas.
