For customer a Pharmaceutical companies in Basel we are looking for:
TRD Quality Project Lead for Medical Device Software and MDSAP
Direct support to the project leads, as well as leading specific initiatives in the project. Provide expertise in SaMD (Software ad medical device) and in MDSAP certification (Medical Device Single Audit Program). Lead, guide and support global project workstreams in all quality-relevant topics, questions, and issues. Develop project strategies in alignment with TRD considering all relevant cross-functional aspects to ensure the quality of deliverables within the project. QA representative at expert panel; Lead QA aspects of assigned new technology projects; Lead preparation for MDSAP certification, ensure inspection site readiness.
- Active support and drive in the global TRD project organisation working on the QMS adaptation for SaMD and MDSAP.
- Lead and drive assigned initiatives within the project. Ensure quality oversight 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 overall strategies and goals and in compliance to cGMP guidelines and internal procedures.
- Understand and proactively manage the interactions between the project organisation and the key involved functions and stakeholders.
- Provide expertise and support on SaMD and MDSAP to the project organisation and provide direct support to the relevant project workstreams
- Active support to the project leads to proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level/ steering committee.
- Lead the preparation for the MDSAP certification, with a focus on the QMS adaptation and readiness for inspection.
- Education: Graduate in a scientific field. Medical device software background. Experience with MDSAP
- Languages: English fluent in speaking / writing, German and/or French desirable.
- At least 3 years of relevant experience.
- Practical experience in managing projects in compliance with ISO 13485, 21 CFR part 820 / part 4, MDSAP, IEC 62304, IEC 82304, ISO 14971, IEC 62366, MDD/MDR, GDPR and other relevant standards and guidances related to medical device software.
- Ability to influence people, negotiate and communicate.
- Sound scientific, technical and regulatory knowledge in a specific area.
- Excellent knowledge of cGMP, working knowledge of medical device software regulations, standards and guidelines.
- Good knowledge of medical device software development and life-cycle management.
- Good organizational skills.
- Good and proven ability to analyze and evaluate GMP compliance.
- Ability to work in cross-functional teams including Quality, Technical Development , Regulatory, Human Factors, Risk Management, IT and other functions
Working Time: flexible working hours
Start Date: 01.02.2021
Duration: 11 months
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Franck Maerky (+41 61 270 80 17).