• An internationally operating, innovative Swiss pharmaceutical company, a leader in its field
• Flexible working hours and extensive training opportunities
• A motivated multicultural team and environment

• Lead and support global TRD project team, and represent TRD QA globally in TRD sub-teams, as well as at global quality board meetings and project development gate meetings.
• Ensure quality oversight on the assigned development projects with strong quality guidance, scientific and technical expertise.
• Contribute to the strategy of assigned projects incl. contingency planning and risk assessments as appropriate to ensure timely achievement of project quality deliverables. Ensure that the strategy followed within the assigned projects is in line with TRD QA strategies and goals and in compliance to cGMP guidelines and internal procedures.
• Understand and proactively manage the interactions of project related activities between TRD QA and other departments inside or outside of TRD.
• Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level, to the TRD project leader and/or to any other relevant project team member(s).
• Represent TRD QA in Due Diligence teams, provide quality assessment of potential inlicensing products in a timely manner and support follow-up activities as appropriate.

• Fundamental, broad understanding and knowledge of quality standards and policies in Drug Substance/Drug Product/Medical Devices manufacturing and control.
• Experience with Health Authority Inspections (FDA and EMA in particular), and knowledge of RegCMC requirements for Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs).
• Broad experience in technical drug development as well as in Quality Assurance and/or Quality Control departments. Experience in Technical Operations or equivalent experience from external company is preferred. Proven track record in successfully leading interdisciplinary teams, e.g. scientists working on technical or methodological projects, in TRD or equivalent experience from external company or other line function.
• Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems and associated processes.
• Bachelor (10 years’ pharma quality or operations) or Masters (5 years’ pharma quality or operations)
• Fluent English required (oral & written). Good skills in site (local) language desired (oral).

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