Quality Compliance Manager - Europe Cluster (Part-time)
Remote · Part Time
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- Experience
- 5–7 yrs
- Salary
- —
- Openings
- 1
- Posted
- 2 weeks ago
- Work mode
- Work from home
- Education
- Degree in Pharmacy or Life Sciences
- Resume
- Required to apply
Job description
About EVA Pharma
EVA Pharma is a prominent pharmaceutical company committed to advancing health as a fundamental human right. Renowned as an excellent workplace, the company fosters an encouraging and innovative environment for its employees.
Role Overview
The position of Quality Compliance Manager (Part-Time) involves overseeing and enhancing the German Quality Management System (QMS) to uphold conformity with German and European pharmaceutical regulations. The role includes managing quality processes, inspections, audits, training, supplier validations, CAPA handling, and monitoring the quality standards of external partners, ensuring full compliance with GxP and readiness for inspections.
Key Responsibilities
- Maintain and improve local Quality Management System documentation and processes.
- Manage SOPs, forms, records, and schedule regular document reviews.
- Administer staff training and qualification programs to ensure compliance standards are met.
- Lead qualification procedures for suppliers, customers, and service providers.
- Organize, conduct, and follow up on internal audits and quality evaluations.
- Handle deviations, quality incidents, CAPA initiatives, and continuous improvement actions.
- Coordinate quality aspects with manufacturers, external service providers, and batch release partners.
- Prepare for and support regulatory inspections while maintaining continual inspection readiness.
Candidate Requirements
- Academic degree in Pharmacy, Life Sciences, or a related science field.
- 5 to 7 years of experience managing pharmaceutical or healthcare quality systems.
- Proven experience as a Responsible Person for Wholesale Distribution in accordance with German Medicines Act (AMG §52a).
- In-depth understanding of GxP, German pharmaceutical laws, and EU compliance regulations.
- Able to manage diverse quality activities and collaborate effectively with various internal and external stakeholders.
Employment Details
This is a part-time, fully remote role based in Germany.