BeOne
Director, Product Quality Lead(m/w/x)
Full-timeOn-siteSenior
Basel
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BABayer
Cell and Gene Therapy (CGT) Quality Program Owner(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Designing and implementing quality programs for late-stage Cell and Gene Therapy products across platforms. PhD/MD in relevant life sciences and late-stage CGT product experience required. Mission-driven work in global health.
Requirements
- PhD/MD in Biotechnology, Virology, Cell-Engineering, Pharmaceutical-technology, or related field
- Experience with late-stage development and marketed CGT products
- In-depth understanding of regulatory requirements (CGT, ATMPs)
- Grasp of technologies for gene therapy products
- Experience writing regulatory documents and cGMP environment
- Visionary leadership qualities
- Practical mindset in ATMP advancement
- Deep understanding of CGT regulatory requirements and interactions
- Collaborative leadership qualities
- Strong interpersonal skills
- Excellent communication and negotiation skills
Tasks
- Design, develop, and implement core Quality programs.
- Set quality standards and requirements for CGT activities.
- Advance Quality requirements for the CGT area.
- Guide roadmap implementation in a dynamic environment.
- Ensure quality of CGT products across platforms.
- Build global processes for program standards.
- Establish a QMS program and roadmap.
- Ensure regulatory compliance from development to commercial phases.
- Ensure compliance with QMS standards.
- Advocate for quality across all relevant departments.
- Provide expertise in regulatory requirements.
- Facilitate FDA inspection readiness for ATMP facilities.
- Foster open communication and collaboration among stakeholders.
- Build and maintain strong stakeholder relationships.
- Build Quality Assurance and Quality Control programs for CGT production, early to industrial scale-up.
- Provide expertise and guidance to CGT Affiliate sites.
- Ensure compliance with CGT program expectations.
- Manage the contract testing laboratories network.
- Participate in industry collaborations to monitor trends.
Work Experience
- approx. 4 - 6 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bayer 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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BABayer
Cell and Gene Therapy (CGT) Quality Program Owner(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Designing and implementing quality programs for late-stage Cell and Gene Therapy products across platforms. PhD/MD in relevant life sciences and late-stage CGT product experience required. Mission-driven work in global health.
Requirements
- PhD/MD in Biotechnology, Virology, Cell-Engineering, Pharmaceutical-technology, or related field
- Experience with late-stage development and marketed CGT products
- In-depth understanding of regulatory requirements (CGT, ATMPs)
- Grasp of technologies for gene therapy products
- Experience writing regulatory documents and cGMP environment
- Visionary leadership qualities
- Practical mindset in ATMP advancement
- Deep understanding of CGT regulatory requirements and interactions
- Collaborative leadership qualities
- Strong interpersonal skills
- Excellent communication and negotiation skills
Tasks
- Design, develop, and implement core Quality programs.
- Set quality standards and requirements for CGT activities.
- Advance Quality requirements for the CGT area.
- Guide roadmap implementation in a dynamic environment.
- Ensure quality of CGT products across platforms.
- Build global processes for program standards.
- Establish a QMS program and roadmap.
- Ensure regulatory compliance from development to commercial phases.
- Ensure compliance with QMS standards.
- Advocate for quality across all relevant departments.
- Provide expertise in regulatory requirements.
- Facilitate FDA inspection readiness for ATMP facilities.
- Foster open communication and collaboration among stakeholders.
- Build and maintain strong stakeholder relationships.
- Build Quality Assurance and Quality Control programs for CGT production, early to industrial scale-up.
- Provide expertise and guidance to CGT Affiliate sites.
- Ensure compliance with CGT program expectations.
- Manage the contract testing laboratories network.
- Participate in industry collaborations to monitor trends.
Work Experience
- approx. 4 - 6 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bayer 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
Bayer
Industry
Pharmaceuticals
Description
Das Unternehmen ist entschlossen, die größten Herausforderungen unseres Planeten zu überwinden und zu einer Welt beizutragen, in der genug Nahrung und ausreichende medizinische Versorgung für alle Menschen erreichbar sind.
Not a perfect match?
- BeOne
Director, Product Quality Lead(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Affiliate Network Regional Quality Lead(m/w/x)
Full-timeOn-siteExperiencedBasel - BeOne Medicines USA, Inc.
Associate Director, QMS Process Improvement and Analytics(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Head of Compliance and Quality Governance(m/w/x)
Full-timeOn-siteSeniorKaiseraugst - 1201 F. Hoffmann-La Roche AG
CGT Strategic Analytics & Business Insights Lead(m/w/x)
Full-timeOn-siteSeniorBasel