Technical QA Manager (m/f/d)

Start date: As soon as possible

Duration: 1 year/possible extension

Workload: 100%

Location: Basel, on-site


  • QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within TR&D in Base
  • Support of implementation of DI requirements
    Review and approval of GMP relevant Documents like Plans, Reports, SOPs, Change Control, Discrepancy Management, CAPA (corrective action and preventive action), Risk Analysis
  • Assist management in regulatory inspections and performing internal as well as partner audits Ensure adherence to cGMP requirements and Roche policies and standards in technical development functions
  • Apply advanced theory, quality principles, expert judgment and cross functional expertise to address complex problems independently
  • Provide technical and quality assurance input to review and approval of manufacturing and Quality related documents as appropriate, Serve as a Subject Matter Expert (SME) in support of departmental functions and build partnerships and collaborate with stakeholders in other areas of the business to ensure success of the quality.
  • Leading of complex risk assessments Leading resolutions of quality issues and establish work priorities to meet targets and timelines
  • Creation and periodic review of quality agreements (QAGs) with contract organizations including quality agreements
  • Cost conscious working and optimization of processes. Ensure the efficient use of the available resources (staff, equipment, machinery, working spaces, materials).
  • Assistance is required in the introduction and training of new employees


  • Degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
  • Fluent German is mandatory
  • Min. 5 years of Quality Management related experience in the Pharmaceutical industr
  • Experience in Qualification/Validation and CSV of Small Molecules, Analytics and/or Biologics
  • Sound understanding on current DI (Data Integrity) requirements
  • Experience with MES (Manufacturing Execution System)
  • Profound knowledge of global quality and GMP requirements and a detailed understanding of current industrial trends in IMP

Apply for this job

Does this job fit your talents and seem right for you? Don't hesitate to apply online now.

Facts about the job

Contract type
Coopers Group AG