IMP Quality Manager (m/f/d)

For a large pharmaceutical company, an IMP (Investigational Medicinal Product) Quality Manager is sought to ensure GMP compliance and quality of investigational products.

Typical responsibilities in this role:

• Review and approval of manufacturing and batch protocols (Batch Records) for drug substance and drug product.
• Execution of final quality release of investigational products for use in clinical trials.
• Review and approval of GMP-relevant documents such as SOPs, validation reports, deviations and change control requests.
• Creation and maintenance of product-specific quality agreements with internal and external partners.
• Support for production and QC departments on all GMP-related questions and quality issues.
• Planning and conducting internal audits and support during regulatory inspections and external audits.
• Management and oversight of CAPA (Corrective and Preventive Actions) measures for sustainable problem resolution.

Relevant technologies, tools or methods:

• Quality management systems (QMS): Veeva Vault QMS, MasterControl, TrackWise, SAP QM.
• Document Management Systems (DMS): Veeva Vault, OpenText Documentum.
• ERP systems: SAP S/4HANA (especially QM module).
• Laboratory Information Management Systems (LIMS).
• Manufacturing Execution Systems (MES).
• Methods: risk analysis (FMEA), root cause analysis (5 Whys, Ishikawa), statistical process control (SPC).

Typical KPIs or success metrics:

• Batch Release Time: average time from production completion to final release (target: < X days).
• Right-First-Time Rate: percentage of batches released without deviations or rework (target: > 95%).
• CAPA Effectiveness: reduction in recurrence rate of deviations after CAPA implementation (target: > 80%).
• Audit Performance: number of critical/major findings in internal and external audits (target: 0).
• Deviation Closure Rate: percentage of deviations closed within the defined timeframe (target: > 90%).

Key challenges, risks or specifics:

• High complexity and variability due to the development of new molecules and processes in the clinical phase.
• Strict adherence to constantly evolving GMP regulations (e.g. EU Annex 1 for sterile products).
• Ensuring product quality and patient safety under high time pressure (time-to-market).
• Managing interfaces between development, manufacturing, QC, and regulatory affairs.
• Risk of supply chain interruptions for critical raw materials or services.
• Ensuring data integrity in all quality-relevant systems.

Concrete deliverables:

• Released batches of investigational products.
• Approved master batch records and SOPs.
• Completed and assessed deviation and change reports.
• Audit and inspection reports with tracked action plans.
• Valid quality agreements with all relevant partners.
• Regular quality reports for management.

• Must-Haves:**
• Completed degree in a scientific field (Pharmacy, Chemistry, Biology, Biotechnology).
• At least 5 years of professional experience in the GMP-regulated environment of the pharmaceutical industry (QA, QC, manufacturing).
• In-depth knowledge of cGMP requirements, especially for the manufacturing and testing of (parenteral) investigational products.
• Experience in reviewing batch documentation and releasing medicinal products.
• Experience with quality systems (deviations, CAPA, change control).

Nice-to-Haves:

• Experience as a Qualified Person (QP) or corresponding qualification.
• Certifications in quality management (e.g. DGQ/EOQ Quality Manager).
• Experience with audits and regulatory inspections (e.g. Swissmedic, EMA, FDA).
• Knowledge of Veeva Vault and SAP.

Personal attributes and mindset:

• Strong quality awareness and very high attention to detail.
• Strong analytical skills and a structured, solution-oriented approach.
• Excellent communication and negotiation skills to liaise between different departments.
• Decisiveness and the ability to make sound risk assessments under pressure.
• Team player, but also high level of autonomy and assertiveness.