The Manager, IMP Quality Europe is responsible for ensuring compliance and quality oversight of Investigational Medicinal Products (IMPs) across internal and external operations in Europe. This role focuses on GxP compliance, deviation management, regulatory alignment, and cross-functional collaboration to uphold the highest quality standards for clinical trials and commercial distribution.
The ideal candidate will have deep expertise in IMP regulations, GMP/GDP, and EU legislative requirements, with a strong ability to lead investigations, drive corrective actions, and ensure seamless compliance across stakeholders.
Key Responsibilities
1. IMP Quality Oversight & Compliance
* Lead and troubleshoot quality investigations (e.g., temperature excursions, deviations, complaints) for IMPs at internal sites and external partners (CMO/CDMOs).
* Ensure thorough root-cause analysis (RCA) and corrective/preventive actions (CAPA) are implemented in alignment with GxP, ICH, and EU regulations.
* Act as a Quality Subject Matter Expert (SME) for Deviation Management, Change Control, and Complaint Handling in the IMP space.
2. Regulatory & Legislative Compliance
* Collaborate closely with EU Qualified Persons (QPs) to ensure compliance with:
* Directive 2001/83/EC (Human Medicinal Products)
* Clinical Trial Regulation (EU) 536/2014
* Delegated Regulation (EU) 2017/1569 (GMP for IMPs)
* Mutual Recognition Agreements (MRA)
* Support regulatory filings, audits, and inspections (e.g., EMA, Swissmedic, FDA).
3. Cross-Functional Collaboration
* Work with Supply Chain, Manufacturing, Clinical Operations, and Regulatory Affairs to resolve quality issues impacting global and EU stakeholders.
* Develop and update quality policies, SOPs, and training programs for IMP handling, storage, and distribution.
* Coordinate with Swiss Responsible Person (RP)/Deputy RP to ensure compliance with Swiss-specific IMP requirements.
4. Quality Agreements & Performance Metrics
* Lead, negotiate, and maintain Quality Agreements with CMO/CDMOs, distributors, and internal stakeholders, ensuring alignment with GMP, GDP/GSP, and Swiss/EU laws.
* Monitor and report KPIs (e.g., deviation trends, CAPA effectiveness, audit findings) to senior management via Management Review Meetings.
* Analyze performance data and drive continuous improvement initiatives across IMP operations.
5. Training & Process Improvement
* Develop training materials on IMP quality standards, GDP, and regulatory expectations.
* Identify gaps in quality processes and implement practical, compliant solutions to enhance operational efficiency.
Technical & Regulatory Expertise
* Bachelor’s degree in Life Sciences, Pharmacy, or related field (or equivalent experience).
* Minimum 5+ years in IMP Quality, GMP/GDP, or Clinical Supply Chain (pharma/biotech).
* EU IMP regulations (CTR 536/2014, GMP Annex 13, GDP Guidelines)
* Swiss IMP requirements (HMG, Swissmedic guidelines)
* ICH GCP, FDA 21 CFR Part 58 (GLP), and ISO standards
* Deviation investigations & CAPA management
* Quality Agreements & vendor audits
* Temperature-controlled logistics (cold chain, IATA, GDP)
* Direct experience with EU QP oversight (collaboration with QPs).
* Familiarity with clinical trial supply chains (IVRS, labeling, comparators).
* Certifications in GMP, GDP, or Quality Management (e.g., ASQ, IRCA).
* Fluency in English (additional EU languages a plus).
* Problem-solving mindset with ability to drive issues to resolution
* Strong stakeholder management (internal teams, CMOs, regulators)
* Excellent communication (written & verbal) for reports, training, and audits
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