Project Manager in Medical Device/QA (m/f/d), 100%

• 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).
• Provide input to contracts and QA agreements with third parties. Approve project-specific QA agreement amendments for assigned projects.
• Lead or participate in global and/or cross-functional initiatives.
• Prepare and guide TRD project teams for Mock-PAI and PAI in the frame of the PAI preparation process and submission preparation.

• Minimum: Bachelor Degree > 10 years' pharma quality or opeations)
• Desirable: Masters Degree > 5 years' pharma quality or operations)
• Languages: fluent English required (oral + written), Good skills in German or French
• Fundamental, broad understanding and knowledge of quality standards and policies in Drug Product/Medical Devices (combination products) manufacturing and control.
• Experience with Health Authority Inspections (FDA and EMA in particular), Notified Body inspections and knowledge of RegCMC requirements for NB, Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs).
• Broad experience in combination product development as well as in Quality Assurance and/or Quality Control departments.
• Experience in Technical Operations or equivalent experience.
• Proven track record in successfully supporting interdisciplinary teams, e.g. scientists working on technical or methodological projects, in TRD or equivalent experience.
• Ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills.

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