Senior QMS & Compliance Expert everyone
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Job Location:
Visp - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 tomorrows 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
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
Why us
We offer a dynamic environment where you can contribute meaningfully collaborate with exceptional minds and unlock your full potential.
Heres what sets ten23 apart:
Heres what sets ten23 apart:
- A valuable and impactful career development opportunity in an inspiring environment
- Flexible working arrangements and environment with an open culture and diverse workforce
- The opportunity to work with and learn from highly qualified and experienced employees
- Our learning and self-developing culture offers a wide range of training options
- Competitive pension fund plan annual bonus and other financial and non-financial benefit
Contact
For more information and clarification please connect Amrith () 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 Experience:
Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.
Learn about ten23 Experience:
Senior IC
Key Skills
- Digital Marketing
- Marketing
- Google Analytics
- Growing Experience
- Conversion Optimization
- Google AdWords
- Hybris
- Magento
- Account Management
- SEO
- E-Commerce
- Analytics
About Company
The partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines.
