About Us
ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.
Your mission
We are looking for a Senior QMS & Compliance Expert to join our Quality Assurance team in Visp. You will play a key role in driving inspection readiness and management, robust Quality Risk Management (QRM) practices and continuous improvements the Quality Management System (QMS).
Key Responsibilities- Plan, coordinate, perform, and track health authority inspections (e.g. FDA, Swissmedic), customer audits, and self-inspections
- Act as a primary QA contact during inspections, including direct interaction and on-site management of inspectors.
- Prepare, manage, and track CAPA plans, including coordination with internal stakeholders and customers
- Own and manage core quality processes, including Audit and Inspection Management, Deviations, CAPAs, Change Control, Document Management and Training
- Lead and support Quality Risk Management (QRM) activities in line with ICH Q9, including:
- Risk assessments and risk mitigation strategies
- Establishment, maintenance, and governance of the risk register
- Ensuring risks are appropriately documented, reviewed, and escalated
- Support the maintenance, implementation, and continuous improvement of QMS processes
- Author, review, and approve SOPs and quality documentation in compliance with GMP requirements
- Support inspection follow-up activities, including responses to observations and commitments to health authorities
Your profile
We are looking for someone with:
- Minimum 8-10 years of experience in Quality Assurance and Compliance within a GMP-regulated pharmaceutical environment
- Demonstrated experience leading and managing health authority inspections, with direct, hands-on interaction with FDA and Swissmedic inspectors
- Strong background in pharmaceutical GMP manufacturing, ideally sterile manufacturing
- Proven expertise in Quality Risk Management (QRM), including ownership and governance of risk registers
- In-depth knowledge of GMP regulations, guidelines, and industry best practices (e.g. EU GMP, FDA, ICH, Annex 1)
- Strong leadership, communication, and stakeholder management skills, including the ability to influence senior levels
- Structured, resilient, and confident in high-pressure regulatory situations
- Experience with customer audits as a CDMO is a plus
- Fluent in written and spoken English, German as a plus
Contact
For more information and clarification, please connect Amrith (amrith.kiran@ten23.health) from our Talent team!
About us
While most applicants fall short of 100% qualifications, we embrace diverse perspectives and encourage applications from all qualified candidates, regardless of background. Women & underrepresented groups, we see you!
Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.
Learn about ten23,
https://www.youtube.com/watch?v=HgS3wd03JV0
