CH12 Lonza AG
Senior QA Specialist, QA Project Management(m/w/x)
Full-timeOn-siteSenior
Visp
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TEten23 health
Senior QMS & Compliance Expert(m/w/x)
Visp
Full-timeOn-siteSenior
Nejo AI Summary
Planning and coordinating health authority inspections for pharmaceutical and biotech medicine development. 8-10 years in GMP-regulated pharma QA/Compliance, leading FDA/Swissmedic inspections required. Flexible working arrangements.
Requirements
- 8-10 years of experience in Quality Assurance and Compliance within a GMP-regulated pharmaceutical environment
- Experience leading and managing health authority inspections 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
- 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
Tasks
- Plan and coordinate health authority inspections
- Perform and track customer audits and self-inspections
- Act as the primary QA contact during inspections
- Prepare and manage CAPA plans with stakeholders
- Own and manage core quality processes
- Lead Quality Risk Management activities
- Conduct risk assessments and develop mitigation strategies
- Establish and maintain the risk register
- Document, review, and escalate risks appropriately
- Support continuous improvement of QMS processes
- Author, review, and approve SOPs and quality documentation
- Support follow-up activities for inspections
Work Experience
- 8 - 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Flexible Working
- Flexible working arrangements
Informal Culture
- Open culture
- Diverse workforce
Learning & Development
- Wide range of training options
Retirement Plans
- Competitive pension fund plan
Bonuses & Incentives
- Annual bonus
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
Senior QMS & Compliance Expert(m/w/x)
Visp
Full-timeOn-siteSenior
Nejo AI Summary
Planning and coordinating health authority inspections for pharmaceutical and biotech medicine development. 8-10 years in GMP-regulated pharma QA/Compliance, leading FDA/Swissmedic inspections required. Flexible working arrangements.
Requirements
- 8-10 years of experience in Quality Assurance and Compliance within a GMP-regulated pharmaceutical environment
- Experience leading and managing health authority inspections 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
- 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
Tasks
- Plan and coordinate health authority inspections
- Perform and track customer audits and self-inspections
- Act as the primary QA contact during inspections
- Prepare and manage CAPA plans with stakeholders
- Own and manage core quality processes
- Lead Quality Risk Management activities
- Conduct risk assessments and develop mitigation strategies
- Establish and maintain the risk register
- Document, review, and escalate risks appropriately
- Support continuous improvement of QMS processes
- Author, review, and approve SOPs and quality documentation
- Support follow-up activities for inspections
Work Experience
- 8 - 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Flexible Working
- Flexible working arrangements
Informal Culture
- Open culture
- Diverse workforce
Learning & Development
- Wide range of training options
Retirement Plans
- Competitive pension fund plan
Bonuses & Incentives
- Annual bonus
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.
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