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 the quality of investigational products.

• Typical responsibilities in this role:**

• Review and release of manufacturing and batch records for drug substances and drug products.

• Execution of the 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 of production and QC departments on all GMP and quality topics.

• Planning and conducting internal audits and support during regulatory inspections and external audits.

• Management and monitoring of CAPA 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 the 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 end of production to final release (Target: < X days).

• Right-First-Time Rate: Percentage of batches released without deviations or rework (Target: > 95%).

• CAPA Effectiveness: Reduction in repeat 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 time frame (Target: > 90%).

• Key challenges, risks or specifics:**

• High complexity and variability due to development of new molecules and processes in clinical phase.

• Strict adherence to evolving GMP regulations (e.g., EU Annex 1 for sterile products).

• Ensuring product quality and patient safety under tight time-to-market pressure.

• Managing interfaces between R&D, manufacturing, QC, and regulatory affairs.

• Risk of supply chain disruptions for critical raw materials or services.

• Ensuring data integrity across all quality-relevant systems.

• Concrete deliverables:**

• Released batches of investigational products.

• Approved master batch records and SOPs.

• Completed and reviewed 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:**

• Degree in a life science discipline (Pharmacy, Chemistry, Biology, Biotechnology).

• At least 5 years of experience in a GMP-regulated environment within the pharmaceutical industry (QA, QC, Manufacturing).

• In-depth knowledge of cGMP requirements, especially for manufacturing and testing of (parenteral) investigational products.

• Experience reviewing batch documentation and releasing pharmaceutical products.

• Experience with quality systems (deviations, CAPA, change control).

• Nice-to-Haves:**

• Experience as a Qualified Person (QP) or equivalent qualification.

• Certifications in quality management (e.g., DGQ/EOQ Quality Manager).

• Experience with audits and regulatory inspections (e.g., Swissmedic, EMA, FDA).

• Familiarity with Veeva Vault and SAP.

• Personal qualities and mindset:**

• Strong quality awareness and high attention to detail.

• Excellent analytical skills and a structured, solution-oriented approach.

• Outstanding communication and negotiation skills to liaise across departments.

• Decisiveness and the ability to make solid risk assessments under pressure.

• Team player with high personal responsibility and assertiveness.