The main purpose of this role will be to ensure that a Quality Compliance System is in place, securing compliance of activities, quality risk management, escalation of risks, and continuous improvement.
You will ensure that each site within the group receives the right level of support to maintain and enhance GMP compliance and to solve quality-related service issues.
Primary Responsibilities
- Input, Review, and Endorsement of core activities for Combination Products and Medical Devices throughout product life cycle
- Support R&D projects from kickoff to handover, including risk assessments and deficiency letter response
- Support new product launches and transfers
- Contribute to the development and updates of Corporate Standards and oversee the implementation of standards into the sites
- Support complex investigations at the sites to ensure comprehensive, scientific, well-written investigations
- In collaboration with site Compliance and Leadership teams, support the implementation, maintenance, change process, and continuous improvement plans for the site inspection readiness program
- Conducts GRA audits at relevant sites to assess the site state of cGMP compliance
- Support the development and issuance of site Notifications to Management (NTM) of critical events and assessments
- While on the shop floor (QA, Lab, Manufacturing, Packaging, Warehouse) provide coaching, scientific or cGMP guidance, and suggestions for improvement
- Provide support and training to site colleagues in the CMSO segment on the implementation process for corporate standards (QMS)
- Qualifications
- BSc in medical engineering, medical technology, chemistry, microbiology, pharmacy, engineering, or related science-based degree
- Master's Degree preferred - in science, business, healthcare, or an equivalent combination of education and experience related to medical technology and Quality
- 15 years of experience as a functional leader with technical, team management, and operational responsibility. Continuous professional development
- Advanced hands-on practical knowledge in medical technology/engineering and Combination Product/Medical Device manufacturing
- Advanced understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Documentation
- Effective negotiation skills, strong interpersonal skills, excellent presentation skills
- English Language fluency, further languages preferred
