Global Quality Manager (m/f/d) - Quality Assurance / GMP / GDP / Pharma / English

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Global Quality Manager (m/f/d).

Global Quality Manager (m/f/d)

Global Quality Manager (m/f/d) - Quality Assurance / GMP / GDP / Pharma / English

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Global Quality Manager (m/f/d) .

Background:
About the Organization

Join IMP Quality Distribution, a critical function within Global Quality Assurance. We are responsible for maintaining the quality and

compliance of Investigational Medicinal Products (IMP) throughout the clinical supply chain. Our team acts as the appointed Delegate of

the Swiss Responsible Person (FvP) and holds Global QA oversight over the entire IMP Distribution Network (Depots) and our key

business counterparter, Global Clinical Supply Chain Management Distribution (PTDS-L). We drive continuous improvement and ensure

adherence to international GMP/GDP standards.

The Opportunity

We are seeking a highly motivated and experienced Global Quality Manager to step into a role of significant reach. This position is

instrumental in safeguarding product quality and regulatory compliance for global clinical trials. You will utilize your expertise in quality

systems and supply chain distribution knowledge to provide guidance and maintain oversight over complex GxP processes.

The perfect candidate:
An exceptional candidate holds a Bachelor's degree in a relevant scientific or technical field and brings a minimum of three years of comprehensive Quality Assurance experience deeply rooted in a regulated GMP/GDP environment. They are completely fluent in English (with German being a strong asset), allowing them to confidently author Master Quality Agreements, manage clinical trial complaint systems, and articulate compliance strategies during high-stakes Health Authority Inspections. Finally, this individual is a proactive problem-solver who will seamlessly support clinical studies by approving complex IMP Supply & Release Flowcharts while actively driving continuous improvement projects across the distribution network.

Tasks & Responsibilities:

• Regulatory Compliance: Act as the appointed Delegate of the Swiss Responsible Person (FvP), providing necessary final Quality decision-making
• Global Oversight: Maintain Global QA oversight for the entire Roche IMP Distribution Network and its business counterparter PTDS-L.
• Lead the Deviation Management process by performing product quality impact assessments. Provide crucial Quality oversight by reviewing and assessing final evaluations and statements from third parties, ensuring consistency with regulatory standards, and checking if proposed Corrective and Preventive Actions (CAPA) are appropriate.
• System Owner: Manage the full lifecycle of quality documentation and Change Records, including establishing, reviewing, and approving critical documents and changes for both internal procedures and external business documents (PTDS-L).
• Inspection Management: Actively drive and support all GxP inspections and audits.
• Quality Decision-Making: Manage Temperature Excursion Management for clinical trials, including performing assessments and
• managing Expert Statements/Opinions.

Additional Responsibilities & Competencies

• Support clinical studies by reviewing and approving IMP Supply & Release Flowcharts, Transfer requests, and Expert Opinions.
• Establish and approve Master Quality Agreements and Quality Agreements.
• 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
• Professional Discipline: Assure GMP/GDP compliance, adhere to Good Documentation Practices (GDP), and ensure training
• compliance with PQS documents

Must Haves:

• A Bachelor's degree in a relevant scientific or technical field (e.g., Pharmacy, Chemistry, Biology, Engineering)
• Proven and comprehensive experience (min. 3 years) in Quality Assurance with a strong focus on compliance
• Deep knowledge of a regulated GxP environment (GMP/GDP)
• Fluent speaker and writer in English (German is a plus). Fluency is essential for managing critical regulatory documentation, providing authoritative guidance to European sites, and ensuring successful support during Health Authority Inspections

Nice to Haves:

• Familiarity with Veeva vault QMS
• Roche experience
• PTQ experience
• Experience in supplier management especially depots

Reference Nr.: 925022
Role: Global Quality Manager (m/f/d)
Industrie: Pharma
Workplace: Basel
Pensum: 100%
Start: 21.08.2026
Duration: 12++
Deadline: 22.06.2026

If you are interested in this position, please send us your complete dossier. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.

ITech Consult AG
+41417607701