Global Quality Manager (m/f/d) – Quality Assurance / GMP / GDP / Pharma / English
For our client, a leading pharmaceutical company in Basel, we are seeking a highly qualified Global Quality Manager (m/f/d).
Background
About the Organization: Join IMP Quality Distribution, a critical function within Global Quality Assurance. Our team is responsible for maintaining the quality and compliance of Investigational Medicinal Products (IMP) throughout the clinical supply chain. Acting as the appointed Delegate of the Swiss Responsible Person (FvP), we provide global QA oversight over the entire IMP Distribution Network (Depots) and collaborate closely with our key business partner, Global Clinical Supply Chain Management Distribution (PTDS-L). We are committed to driving continuous improvement and ensuring adherence to international GMP/GDP standards.
The Opportunity
We are looking for a motivated and experienced Global Quality Manager to take on a crucial role in safeguarding product quality and regulatory compliance for global clinical trials. You will leverage your expertise in quality systems and supply chain distribution to provide comprehensive guidance and oversight over complex GxP processes.
The Perfect Candidate
The ideal candidate will possess:
- A Bachelor's degree in a relevant scientific or technical field.
- A minimum of three years of extensive Quality Assurance experience within a regulated GMP/GDP environment.
- Fluency in English (German is a strong asset), enabling effective communication in authoring Master Quality Agreements, managing clinical trial complaint systems, and articulating compliance strategies during high-stakes Health Authority Inspections.
- A proactive problem-solving mindset, capable of supporting clinical studies by approving complex IMP Supply & Release Flowcharts and driving continuous improvement projects throughout the distribution network.
Tasks & Responsibilities
- Regulatory Compliance: Act as the Delegate of the Swiss Responsible Person (FvP), responsible for final Quality decision-making.
- Global Oversight: Maintain global QA oversight for the Roche IMP Distribution Network and partner PTDS-L.
- Deviation Management: Lead the Deviation Management process, perform product quality impact assessments, and ensure consistency with regulatory standards.
- System Owner: Manage the lifecycle of quality documentation and Change Records, reviewing and approving critical internal and external documents.
- Inspection Management: Actively drive and support GxP inspections and audits.
- Quality Decision-Making: Manage Temperature Excursion Management for clinical trials and oversee Expert Statements/Opinions.
Additional Responsibilities & Competencies
- Support clinical studies by reviewing and approving IMP Supply & Release Flowcharts and Transfer requests.
- Establish and approve Master Quality Agreements and related documentation.
- Manage Complaint Management for clinical trials within the Roche network.
- Support quality-related and business-driven projects within the IMP Distribution network.
- Drive continuous improvement activities.
- Ensure GMP/GDP compliance and adherence to Good Documentation Practices (GDP).
Must Haves
- A Bachelor's degree in a relevant scientific or technical field (e.g., Pharmacy, Chemistry, Biology, Engineering).
- A minimum of three years of comprehensive experience in Quality Assurance with a focus on compliance.
- Deep knowledge of a regulated GxP environment (GMP/GDP).
- Fluent in English, with proficiency critical for managing regulatory documentation and providing guidance during Health Authority Inspections.
Nice to Haves
- Familiarity with Veeva Vault QMS.
- Experience at Roche.
- PTQ experience.
- Experience in supplier management, particularly with depots.
Reference Nr.: 925022
Role: Global Quality Manager (m/f/d)
Industry: Pharma
Workplace: Basel
Pensum: 100%
Start: 21.08.2026
Duration: 12++
Deadline: 22.06.2026
If you are interested in this position, please apply online using the form below. Only applications matching the job profile will be considered.
About Us
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. We specialize in placing highly qualified candidates in the fields of IT, Life Science, and Engineering. Our staff leasing and payroll services are provided free of charge to candidates, ensuring no additional fees for Payroll services.