QA/Compliance Lead

QA/Compliance Lead

Chemie / Pharma / Biotechnologie
  • Temporär - Vollzeit
  • Referenz : INT-051906
  • Teilen:


  • Region Basel
  • Art des Vertrags Temporär - Vollzeit
  • Tätigkeitssektor Chemie / Pharma / Biotechnologie


As preferred supplier of Roche in Basel we are looking for a

QA/Compliance Lead

with a contract until 30.06.2025 with possible extension. Home Office: max. 40% possible.


• Accountable for local CSV & Quality deliverables defined for the local Deployment
• Definition of local Change Request/Validation/Implementation plans (incl. CSV) and related closure/reports
• Accountable for the local implementation plan, local implementation interim report, local implementation report according to CSV requirements and the respective SOPs
• Coordinate and support adoption of local SOPs triggered by ASPIRE (i.e. definition of the SOP inventory, planning of SOP updates and coordination of SOP updates according to plan)
• Supporting the training activities for ASPIRE
• Supporting test planning, execution, closure and defects
• Supporting data migration, esp., local verification and incidents associated with GxP data
• Supporting local cutover activities to ensure all protocols are completed and deviations accepted
• Supporting any definition of interim ways of working required during cutover
• Defining and supporting any PQ activities if required
• Compliance support for defects, incidents and change controls
• Coaching and training of local ASPIRE team as required in related compliance approaches/deliverables
• Accountability for compliance, quality assurance, deliverable acceptance, and sign-off processes within the ASPIRE project

Erforderliches Profil

• Master Degree: With a successfully completed engineering degree in the field of biotechnology, pharmacology or process engineering, combined with the necessary specialist knowledge for this activity
• Min. 5 years experience in a GMP regulated manufacturing environment and with validation responsibilities ****
• Min. 3 years of experience in quality management in the technical and CSV qualification fields ****
• Extensive experience with the regulatory requirements in the GMP environment ****
• Experience in a matrix leadership role ****
• Compliance work within a project/change environment ****, ideally experience in multi-site/global projects
• Understanding of ERP life cycle, deliverables and the compliance needs/implications
• Experience in previous deployment of global application to site is highly advantageous
• Fluent both in English and German (written/spoken)
• Excellent communication skills: The role requires clear direction locally, but also will involve global/above site engagement for both straightforward communication, and also influencing.
• Very Good x-functional understanding of compliance within a manufacturing site
• Ability to work in a matrix environment. Controlling/developing compliance deliverables and supporting other streams as appropriate
• Ability to understand the nature of risks and promote/support appropriate mitigations
• Coaching/supporting streams
• Ability to influence, esp. within a global team environment
• Ability to work within a multicultural environment


  • Agentur GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
  • Veröffentlicht am 14. September 2023
  • Berater-in Jie Zhu