Project details
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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 product quality of investigational medicinal products.
- Typical areas of responsibility in this role:**
- Review and approval of manufacturing and batch records for Drug Substance and Drug Product.
- 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-related and quality topics.
- Planning and execution of internal audits and support during regulatory inspections and external audits.
- Management and monitoring 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 repeat deviation rate 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 set timeframe (Target: > 90%).
- Key challenges, risks or specifics:**
- High complexity and variability due to development of new molecules and processes in the clinical phase.
- Strict compliance with ever-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 disruptions for critical raw materials or services.
- Ensuring data integrity across all quality-related systems.
- Deliverables:**
- Released batches of investigational products.
- Approved master batch records and SOPs.
- Completed and evaluated deviation and change reports.
- Audit and inspection reports with tracked action plans.
- Valid quality agreements with all relevant partners.
- Regular quality reports for management.
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A company is seeking an experienced engineering expert for sterile filling to support a challenging project in pharmaceutical production. The goal of the project is to optimize the efficiency and quality of filling processes and ensure compliance with all regulatory requirements.
In this role, the expert will work closely with the internal team to develop technical solutions, analyze existing processes and implement improvements.
Main Tasks:
- Analysis and optimization of processes in sterile filling
- Ensuring compliance with GMP and other regulatory requirements
- Development and implementation of technical solutions for process improvement
- Collaboration with interdisciplinary teams
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A leading automotive supplier is seeking an experienced quality expert to inspect weld seams on safety-critical body components. The project involves ensuring the highest quality standards through non-destructive testing methods.
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Freelance Clinical Data Manager (m/f/d)
On behalf of a renowned client in the life sciences sector, we are seeking freelance support in the field of Clinical Data Management. The main responsibility is to coordinate all data management activities in clinical trials.
- Typical areas of responsibility in this role:**
- Creation and review of the Data Management Plan (DMP) and the Data Validation Plan (DVP).
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- Development and execution of query processes to resolve data inconsistencies with investigational sites.
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- Timeliness: Time from Last Patient Last Visit (LPLV) to database lock (target: 4–6 weeks).
- Efficiency: Average time to query resolution (target: < 10 business days for critical queries).
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- Ensuring data integrity and security (cybersecurity, data protection/GDPR).
- Complexity due to mid-study changes (protocol amendments) and their impact on the database.
- Ensuring consistent data quality across globally distributed investigational sites.
- Shortage of qualified specialists and high demands for onboarding study-specific systems.
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- Finalized and approved Data Management Plan (DMP).
- Live and validated study database (EDC system).
- Regular data cleaning reports and status updates.
- Clean, quality-assured database prepared for statistical analysis.
- Final locked study database with complete audit trail.
- Archived project documentation after study completion.
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- The onboarding will primarily be remote, with occasional in-person days in Amsterdam.
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## Service Description without Personal Reference
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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 product quality of investigational medicinal products.
Typical areas of responsibility in this role:**
Review and approval of manufacturing and batch records for Drug Substance and Drug Product.
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-related and quality topics.
Planning and execution of internal audits and support during regulatory inspections and external audits.
Management and monitoring 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 repeat deviation rate 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 set timeframe (Target: > 90%).
Key challenges, risks or specifics:**
High complexity and variability due to development of new molecules and processes in the clinical phase.
Strict compliance with ever-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 disruptions for critical raw materials or services.
Ensuring data integrity across all quality-related systems.
Deliverables:**
Released batches of investigational products.
Approved master batch records and SOPs.
Completed and evaluated 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:**
Completed degree in a scientific field (Pharmacy, Chemistry, Biology, Biotechnology).
At least 5 years of professional experience in a GMP-regulated environment within the pharmaceutical industry (QA, QC, Manufacturing).
In-depth knowledge of cGMP requirements, especially for the production and testing of (parenteral) investigational products.
Experience in reviewing batch documentation and releasing medicinal products.
Proficiency in 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).
Knowledge of 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.
Exceptional communication and negotiation skills to liaise between departments.
Decisiveness and the ability to perform sound risk assessments under pressure.
Team player with a high degree of personal responsibility and assertiveness.
English
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