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IMP Quality Manager (m/f/d)
Industry
Pharmaceutical
Area
Quality Assurance (QA)
Project info
- Period07.07.2025 - 07.10.2025
- Capacityfrom 90%
- Daily rate780 - 1060€
- LocationCologne, Germany
- Language
- German(Native)
- German
- Remote10 - 30%
Description
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.
Requirements
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.