Global quality manager (m/f/d)

PbGlobal Quality Manager (m/f/d) /bb – /bbQuality Assurance /bb/ /b bGMP /bb/ /b bGDP / /bbPharma /bb/ /bbEnglish /b /p pbProject: br/ /bFor our customer a big pharmaceutical company in Basel we are looking for a highly qualified bGlobal Quality Manager (m/f/d) /bb. /b /ppb Background:br/ /bAbout the Organization /p pJoin IMP Quality Distribution, a critical function within Global Quality Assurance. We are responsible for maintaining the quality and /p pcompliance of Investigational Medicinal Products (IMP) throughout the clinical supply chain. Our team acts as the appointed Delegate of /p pthe Swiss Responsible Person (FvP) and holds Global QA oversight over the entire IMP Distribution Network (Depots) and our key /p pbusiness counterparter, Global Clinical Supply Chain Management Distribution (PTDS-L). We drive continuous improvement and ensure /p padherence to international GMP/GDP standards. /p pThe Opportunity /p pWe are seeking a highly motivated and experienced Global Quality Manager to step into a role of significant reach. This position is /p pinstrumental in safeguarding product quality and regulatory compliance for global clinical trials. You will utilize your expertise in quality /p psystems and supply chain distribution knowledge to provide guidance and maintain oversight over complex GxP processes. /p p bThe perfect candidate: br/ /bAn 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. /p p bTasks Responsibilities: /b /p liRegulatory Compliance: Act as the appointed Delegate of the Swiss Responsible Person (FvP), providing necessary final Quality decision-making /li liGlobal Oversight: Maintain Global QA oversight for the entire Roche IMP Distribution Network and its business counterparter PTDS-L. /li liLead 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. /li liSystem 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). /li liInspection Management: Actively drive and support all GxP inspections and audits. /li liQuality Decision-Making: Manage Temperature Excursion Management for clinical trials, including performing assessments and /li limanaging Expert Statements/Opinions. /li pAdditional Responsibilities Competencies /p liSupport clinical studies by reviewing and approving IMP Supply Release Flowcharts, Transfer requests, and Expert Opinions. /li liEstablish and approve Master Quality Agreements and Quality Agreements. /li liManage Complaint Management for clinical trials within the Roche network. /li liSupport quality-related and business-driven projects within the IMP Distribution network. /li liDrive continuous improvement activities /li liProfessional Discipline: Assure GMP/GDP compliance, adhere to Good Documentation Practices (GDP), and ensure training /li licompliance with PQS documents /li pbMust Haves: /b /p liA Bachelor’s degree in a relevant scientific or technical field (e.g., Pharmacy, Chemistry, Biology, Engineering) /li liProven and comprehensive experience (min. 3 years) in Quality Assurance with a strong focus on compliance /li liDeep knowledge of a regulated GxP environment (GMP/GDP) /li liFluent 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 /li pbNice to Haves: /b /p liFamiliarity with Veeva vault QMS /li liRoche experience /li liPTQ experience /li liExperience in supplier management especially depots /li pbReference Nr.: /b br/ bRole: /b Global Quality Manager (m/f/d)br/ bIndustrie: /b Pharmabbr/ Workplace: /b Basel br/ bPensum: 100% /bbr/ bStart: /b br/ bDuration: 12++ /bbr/ bDeadline /b: /p p If you are binterested /b 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. /p pbContact us /b for more information about our company, our positions or our attractive Payroll-Only programme: . /p pbAbout us /b: /p pITech 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. /p pWe offer staff leasing payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees. /p