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QA Operations Manager (Contamination Control)(m/w/x)
Ensuring end-to-end GMP compliance for microbial manufacturing assets at a biopharmaceutical leader, authoring critical documentation. Audit experience with Swissmedic/FDA/EMA regulations required. Regular interaction with international regulatory bodies.
Requirements
- Degree in Life Sciences or related field
- Experience in GMP-regulated environment, ideally biopharmaceutical
- Proactive, detail-oriented, problem-solving and improvement mindset
- Experience in customer-focused stakeholder management
- Audit experience with Swissmedic/FDA/EMA regulations
- Background in contamination control and monitoring
- Fluency in English; German an asset
Tasks
- Lead asset-specific contamination prevention strategies
- Ensure end-to-end compliance across microbial manufacturing
- Author and approve critical GMP documentation
- Review SOPs, deviations, and change controls
- Conduct comprehensive quality risk assessments
- Serve as primary QA expert during inspections
- Manage microbial topics for customer and internal audits
- Partner with cross-functional teams to identify risks
- Drive deviation management and continuous improvement
- Strengthen contamination prevention control practices
- Provide microbiology and QA expertise to stakeholders
- Foster a robust quality culture and operational compliance
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- GMP
- Swissmedic
- FDA
- EMA
Benefits
Career Advancement
- Agile career
Informal Culture
- Dynamic working culture
Purpose-Driven Work
- Inclusive and ethical workplace
Bonuses & Incentives
- Performance-based compensation programs
Not a perfect match?
- CH12 Lonza AGFull-timeOn-siteSeniorVisp
- Lonza
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QA Operations Manager (Contamination Control)(m/w/x)
Ensuring end-to-end GMP compliance for microbial manufacturing assets at a biopharmaceutical leader, authoring critical documentation. Audit experience with Swissmedic/FDA/EMA regulations required. Regular interaction with international regulatory bodies.
Requirements
- Degree in Life Sciences or related field
- Experience in GMP-regulated environment, ideally biopharmaceutical
- Proactive, detail-oriented, problem-solving and improvement mindset
- Experience in customer-focused stakeholder management
- Audit experience with Swissmedic/FDA/EMA regulations
- Background in contamination control and monitoring
- Fluency in English; German an asset
Tasks
- Lead asset-specific contamination prevention strategies
- Ensure end-to-end compliance across microbial manufacturing
- Author and approve critical GMP documentation
- Review SOPs, deviations, and change controls
- Conduct comprehensive quality risk assessments
- Serve as primary QA expert during inspections
- Manage microbial topics for customer and internal audits
- Partner with cross-functional teams to identify risks
- Drive deviation management and continuous improvement
- Strengthen contamination prevention control practices
- Provide microbiology and QA expertise to stakeholders
- Foster a robust quality culture and operational compliance
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- GMP
- Swissmedic
- FDA
- EMA
Benefits
Career Advancement
- Agile career
Informal Culture
- Dynamic working culture
Purpose-Driven Work
- Inclusive and ethical workplace
Bonuses & Incentives
- Performance-based compensation programs
About the Company
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Not a perfect match?
- CH12 Lonza AG
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Full-timeOn-siteSeniorVisp - Lonza
Microbial Contamination Control Expert(m/w/x)
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