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Job Summary
The Quality Compliance Manager (Part-Time) is responsible for maintaining and continuously improving the German Quality Management System (QMS), ensuring compliance with German and EU pharmaceutical regulations. The role oversees quality processes, inspections, audits, training, supplier qualification, CAPA management, and quality oversight of external partners to ensure the organization remains inspection-ready and fully compliant with GxP requirements.
Key Responsibilities
- Maintain and continuously improve the local Quality Management System (QMS).
- Manage quality documentation, including SOPs, forms, records, and periodic reviews.
- Coordinate employee training, qualification programs, and compliance records.
- Lead supplier, customer, and service provider qualification activities.
- Plan, conduct, and follow up on internal audits and quality assessments.
- Manage deviations, quality events, CAPAs, and process improvement initiatives.
- Oversee quality-related interfaces with manufacturers, external service providers, and batch release partners.
- Prepare for, coordinate, and support regulatory authority inspections while ensuring ongoing inspection readiness.
Employment Type
Part-Time | Remote (Germany-based)
Requirements
- Degree in Pharmacy, Life Sciences, or a related scientific discipline.
- Minimum 5-7 years of experience in pharmaceutical or healthcare quality management systems.
- Experience as a Responsible Person for Wholesale Distribution under German Medicines Act (AMG §52a).
- Strong knowledge of GxP requirements, German pharmaceutical regulations, and EU compliance standards.
- Manage multiple quality activities, and effectively interact with internal and external stakeholders.
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