ten23 health
Senior QMS & Compliance Expert(m/w/x)
Full-timeOn-siteSenior
Visp
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TEten23 health
Supplier Quality, QMS and Compliance Expert(m/w/x)
Visp
Full-timeOn-siteSenior
Nejo AI Summary
Supplier quality management and QMS improvement for injectable medicine development. 7+ years QA experience in pharma/biotech with global regulatory framework knowledge required. Flexible working arrangements, diverse workforce.
Requirements
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or related scientific discipline
- 7+ years progressive experience in Quality Assurance (pharmaceutical, biotech, medical device industry) with focus on Supplier Quality Management
- Deep, practical knowledge of global regulatory frameworks (cGMP, EudraLex Vol 4, ICH Q8/Q9/Q10, FDA regulations)
- Extensive experience planning, leading, and executing external supplier audits
- Lead Auditor Certification (ISO 9001, ASQ CQA) highly desirable
- Proven track record managing/optimizing QMS elements (Deviations, CAPAs, Change Controls)
- Authoring complex, legally binding Quality Agreements
- Fluent in English
- Additional languages a plus for global supplier interactions
- Willingness to travel for on-site supplier qualification visits and audits
Tasks
- Lead Supplier Quality Management and Quality Systems activities
- Ensure effective supplier qualification and lifecycle management
- Support maintenance and improvement of the pharmaceutical QMS
- Act as key contact for internal and external stakeholders on quality and compliance
- Establish functional objectives and performance metrics for continuous improvement
- Oversee end-to-end supplier qualification and onboarding processes
- Conduct rigorous due diligence, risk assessments, and periodic evaluations
- Lead supplier audits, remote assessments, and qualification visits
- Drive timely resolution of audit observations and CAPAs
- Negotiate and manage Quality Agreements with suppliers and service providers
- Monitor supplier performance, quality events, and compliance trends
- Escalate and remediate risks immediately
- Support and improve core QMS processes
- Ensure outsourced activities comply with cGMP standards and industry guidelines
- Maintain inspection readiness and manage regulatory inspections
- Partner with Procurement, Operations, QC, Validation, and Regulatory Affairs
- Serve as primary advisor on supplier quality and compliance matters
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
Benefits
Career Advancement
- Career development opportunity
Flexible Working
- Flexible working arrangements
- Flexibility
Informal Culture
- Open culture
- Diverse workforce
- Minimal bureaucracy
Mentorship & Coaching
- Learning from experienced employees
Learning & Development
- Wide range of training options
Retirement Plans
- Competitive pension fund plan
Bonuses & Incentives
- Annual bonus
Other Benefits
- Other financial and non-financial benefits
- Mutual trust
Purpose-Driven Work
- Self-responsibility
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ten23 health and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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TEten23 health
Supplier Quality, QMS and Compliance Expert(m/w/x)
Visp
Full-timeOn-siteSenior
Nejo AI Summary
Supplier quality management and QMS improvement for injectable medicine development. 7+ years QA experience in pharma/biotech with global regulatory framework knowledge required. Flexible working arrangements, diverse workforce.
Requirements
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or related scientific discipline
- 7+ years progressive experience in Quality Assurance (pharmaceutical, biotech, medical device industry) with focus on Supplier Quality Management
- Deep, practical knowledge of global regulatory frameworks (cGMP, EudraLex Vol 4, ICH Q8/Q9/Q10, FDA regulations)
- Extensive experience planning, leading, and executing external supplier audits
- Lead Auditor Certification (ISO 9001, ASQ CQA) highly desirable
- Proven track record managing/optimizing QMS elements (Deviations, CAPAs, Change Controls)
- Authoring complex, legally binding Quality Agreements
- Fluent in English
- Additional languages a plus for global supplier interactions
- Willingness to travel for on-site supplier qualification visits and audits
Tasks
- Lead Supplier Quality Management and Quality Systems activities
- Ensure effective supplier qualification and lifecycle management
- Support maintenance and improvement of the pharmaceutical QMS
- Act as key contact for internal and external stakeholders on quality and compliance
- Establish functional objectives and performance metrics for continuous improvement
- Oversee end-to-end supplier qualification and onboarding processes
- Conduct rigorous due diligence, risk assessments, and periodic evaluations
- Lead supplier audits, remote assessments, and qualification visits
- Drive timely resolution of audit observations and CAPAs
- Negotiate and manage Quality Agreements with suppliers and service providers
- Monitor supplier performance, quality events, and compliance trends
- Escalate and remediate risks immediately
- Support and improve core QMS processes
- Ensure outsourced activities comply with cGMP standards and industry guidelines
- Maintain inspection readiness and manage regulatory inspections
- Partner with Procurement, Operations, QC, Validation, and Regulatory Affairs
- Serve as primary advisor on supplier quality and compliance matters
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
Benefits
Career Advancement
- Career development opportunity
Flexible Working
- Flexible working arrangements
- Flexibility
Informal Culture
- Open culture
- Diverse workforce
- Minimal bureaucracy
Mentorship & Coaching
- Learning from experienced employees
Learning & Development
- Wide range of training options
Retirement Plans
- Competitive pension fund plan
Bonuses & Incentives
- Annual bonus
Other Benefits
- Other financial and non-financial benefits
- Mutual trust
Purpose-Driven Work
- Self-responsibility
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ten23 health and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
ten23 health
Industry
Pharmaceuticals
Description
The company is a human-centric strategic partner for the pharmaceutical industry and biotech start-ups, focusing on the development and testing of medicines.
Not a perfect match?
- ten23 health
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