Quality Manager (GDP / Warehouse Quality)
Location: Germany (On-site / Hybrid depending on candidate location)
Industry: Pharmaceuticals
Employment Type: Full-time
Join a reputable pharmaceutical organisation with a strong focus on quality, compliance, and patient safety. This role offers an excellent opportunity for an experienced Quality Manager to take ownership of quality operations within a pharmaceutical warehouse / distribution environment, ensuring finished products meet all applicable German Health Authority requirements and EU GDP/GMP standards prior to release.
You will play a central role in maintaining inspection readiness, driving continuous improvement across the warehouse quality system, and acting as a key interface with regulatory authorities and internal stakeholders.
Key Responsibilities:
Finished Product Quality & Release: Manage quality review, inspection, and release of finished pharmaceutical products in compliance with German Health Authority requirements (e.g., AMG, AMWHV) and ROB guidelines.
Quality Management System (QMS): Implement, maintain, and continuously improve the QMS in line with GDP, GMP, and local regulatory requirements.
Quality Review & Compliance Oversight: Review batch documentation, certificates of analysis, deviations, change controls, and CAPAs to ensure robust decision-making prior to release.
GDP / Warehouse Compliance: Ensure warehouse operations meet AMG, AMWHV, EU GDP guidelines and relevant local regulations, safeguarding product integrity throughout storage and distribution.
Audit & Inspection Management: Act as the quality point of contact for regulatory inspections and audits, including authority communications and inspection readiness activities.
Audit Programme Delivery: Plan, conduct, and manage internal audits, vendor audits, and third-party audits.
Quality Events Management: Oversee complaint handling, recalls, deviations, OOS investigations, non-conformances, and escalation pathways.
Qualification & Validation: Lead qualification and validation activities relating to warehouse processes, storage conditions, and temperature mapping / monitoring systems.
Training & SOP Compliance: Train warehouse and QA staff on SOPs, quality procedures, and regulatory requirements to maintain a consistent compliance culture.
KPIs & Risk Management: Monitor and report quality KPIs, trends, and risk assessments to management, ensuring proactive issue identification and mitigation.
Cross-Functional Collaboration: Partner closely with Supply Chain, Regulatory Affairs, and Operations to ensure end-to-end compliance and product quality throughout distribution activities.
Qualifications & Experience:
Education: Bachelor’s or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related discipline.
Industry Experience: 7–10 years’ experience in Quality Assurance / Quality Management within the pharmaceutical industry.
GDP / Distribution Background: Prior experience working in a pharmaceutical warehouse or distribution centre environment is essential.
Regulatory Expertise: Strong working knowledge of German pharmaceutical regulations (including AMG and AMWHV) and ROB expectations.
EU Standards: Strong understanding of EU GDP / GMP standards and inspection readiness requirements.
Release Experience: Demonstrable experience managing finished product quality review and release activities.
Why Join Us?
This is a high-impact Quality leadership role within a regulated, fast-moving distribution environment, offering genuine ownership and visibility. You will play a key role in ensuring safe and compliant product release, maintaining strong regulatory relationships, and embedding a proactive quality culture across warehouse operations.