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Senior Quality Assurance Project Manager – Medical Devices & Combination Products (M/F/D)
Tasks:
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
Prepare and guide TRD project teams for Mock-PAI and PAI in the frame of the PAI preparation process and submission preparation
Quality and timelines of strategic project documentation and presentations: Documentation available on time and of high quality (e.g. sound project plans, meeting agenda & minutes, input to project status updates, presentation material, TEDI re-ports, input to TDP, risk assessments (e.g. SWOT)). No impact on project timelines due to inadequate planning
Reliable, timely and accurate information/communication about project specific issues within TRD and to key stake holders
Qualification:
Bachelor + 10 years of Pharma experience
Master Degree +5 years of Pharma experience
English (business fluent) - must have
We are looking for a resource with a big quality rucksack in development, however a top key selection criteria is the experience / having worked in the medical device/ combination product area over years
This medical device/combination product QA experience is a mandatory selection criteria
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 from external company is preferred
Proven track record in successfully supporting interdisciplinary teams, e.g. scientists working on technical or methodological projects, in TRD or equivalent experience from external company or other line function
Requirements:
Start: 01.01.2027
Duration: 12 months
Capacity: 5 days per week
Location: Basel, Switzerland
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