Quality Compliance Manager – Europe Cluster

This is a fully remote position, open to applicants in Germany.

📋 Description

• Oversee and continuously enhance the local Quality Management System (QMS).

• Administer quality documentation, which includes SOPs, forms, records, and regular reviews.

• Organize employee training sessions, qualification programs, and maintain compliance records.

• Direct qualification processes for suppliers, customers, and service providers.

• Plan, execute, and follow up on internal audits and quality evaluations.

• Handle deviations, quality incidents, CAPAs, and initiatives for process improvements.

• Supervise quality-related interactions with manufacturers, external service providers, and partners involved in batch release.

• Prepare for, coordinate, and facilitate inspections by regulatory authorities while ensuring ongoing readiness for inspections.

⛳️ Requirements

• Bachelor’s degree in Pharmacy, Life Sciences, or a related scientific field.

• At least 5-7 years of experience in quality management systems within the pharmaceutical or healthcare sectors.

• Proven experience as a Responsible Person for Wholesale Distribution under the German Medicines Act (AMG §52a).

• Extensive knowledge of GxP requirements, German pharmaceutical regulations, and EU compliance standards.

• Ability to manage multiple quality-related activities and effectively communicate with both internal and external stakeholders.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Collaborative and innovative work environment.

• Flexible work hours and remote work options.