LGC Group
Quality Assurance Manager(m/w/x)
Full-timeWith HomeofficeExperienced
Berlin
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BABayer
Cell and Gene Therapy (CGT) Quality Program Owner(m/w/x)
Berlin, Leverkusen
from 129,700 - 163,800 / year
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Designing and implementing global Quality programs for Cell and Gene Therapies. Several years of CGT Quality Assurance experience required. Hybrid work, variable component.
Requirements
- PhD/MD in Biotechnology, Virology, Cell-Engineering, Pharmaceutical-technology, or related field
- Several years of professional experience in Cell or Gene Therapy Quality Assurance
- Familiarity with manufacturing processes for CGT products
- Familiarity with release criteria for CGT products
- Hands-on approach to advancing ATMPs
- Focus on practical solutions for ATMPs
- Deep understanding of CGT-specific regulatory requirements
- Experience with GxP regulations
- Experience with ATMP regulations
- Experience with regulatory interactions
- Leadership capabilities promoting collaboration
- Leadership capabilities promoting inclusivity
- Breaking down silos within teams
- Coaching mentality for team growth
- Coaching mentality for team learning
- Strong interpersonal skills for quality advocacy
- Demonstrable grasp of qPCR technologies
- Demonstrable grasp of ddPCR technologies
- Demonstrable grasp of ELISA technologies
- Demonstrable grasp of SDS-PAGE technologies
- Demonstrable grasp of in-vivo potency technologies
- Understanding of commercial readiness activities
- Background in Quality Management Systems (QMS)
- Experience with quality audits
- Excellent English communication skills
- Excellent English negotiation skills
Tasks
- Design, develop, and implement core Quality programs for CGT
- Establish Quality standards and requirements for all CGT activities
- Build global processes to ensure CGT product quality
- Drive program standards across Bayer sites with CGT activities
- Establish a Quality Management System program
- Develop an implementation roadmap for the QMS
- Ensure compliance with regulatory requirements (GxP, ATMP)
- Ensure compliance with internal quality standards
- Act as a quality advocate between teams
- Develop strategic plans for CGT Quality Oversight
- Collaborate with the QMS Global team
- Provide expertise in regulatory requirements
- Facilitate FDA inspection readiness activities
- Foster open communication and collaboration
- Encourage discussion and input during meetings
- Ensure SOPs are properly structured and updated
- Ensure quality documents are compliant with regulations
Work Experience
- approx. 1 - 4 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Tools & Technologies
- qPCR
- ddPCR
- ELISA
- SDS-PAGE
- in-vivo potency
Benefits
Other Benefits
- Variable component
Competitive Pay
- Global equity cash plan
Flexible Working
- Hybrid work models
- Part-time arrangements
- Flexible working arrangements
Childcare
- Company daycare centers
- Childcare support
- Children's summer camps
Family Support
- Family care leave
Learning & Development
- Learning and development opportunities
- Bayer Learning Academy training
Mentorship & Coaching
- Development dialogues
- Coaching and mentoring
Healthcare & Fitness
- Free health checks
Informal Culture
- Inclusive work environment
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)
Berlin, Leverkusen
from 129,700 - 163,800 / year
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Designing and implementing global Quality programs for Cell and Gene Therapies. Several years of CGT Quality Assurance experience required. Hybrid work, variable component.
Requirements
- PhD/MD in Biotechnology, Virology, Cell-Engineering, Pharmaceutical-technology, or related field
- Several years of professional experience in Cell or Gene Therapy Quality Assurance
- Familiarity with manufacturing processes for CGT products
- Familiarity with release criteria for CGT products
- Hands-on approach to advancing ATMPs
- Focus on practical solutions for ATMPs
- Deep understanding of CGT-specific regulatory requirements
- Experience with GxP regulations
- Experience with ATMP regulations
- Experience with regulatory interactions
- Leadership capabilities promoting collaboration
- Leadership capabilities promoting inclusivity
- Breaking down silos within teams
- Coaching mentality for team growth
- Coaching mentality for team learning
- Strong interpersonal skills for quality advocacy
- Demonstrable grasp of qPCR technologies
- Demonstrable grasp of ddPCR technologies
- Demonstrable grasp of ELISA technologies
- Demonstrable grasp of SDS-PAGE technologies
- Demonstrable grasp of in-vivo potency technologies
- Understanding of commercial readiness activities
- Background in Quality Management Systems (QMS)
- Experience with quality audits
- Excellent English communication skills
- Excellent English negotiation skills
Tasks
- Design, develop, and implement core Quality programs for CGT
- Establish Quality standards and requirements for all CGT activities
- Build global processes to ensure CGT product quality
- Drive program standards across Bayer sites with CGT activities
- Establish a Quality Management System program
- Develop an implementation roadmap for the QMS
- Ensure compliance with regulatory requirements (GxP, ATMP)
- Ensure compliance with internal quality standards
- Act as a quality advocate between teams
- Develop strategic plans for CGT Quality Oversight
- Collaborate with the QMS Global team
- Provide expertise in regulatory requirements
- Facilitate FDA inspection readiness activities
- Foster open communication and collaboration
- Encourage discussion and input during meetings
- Ensure SOPs are properly structured and updated
- Ensure quality documents are compliant with regulations
Work Experience
- approx. 1 - 4 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Tools & Technologies
- qPCR
- ddPCR
- ELISA
- SDS-PAGE
- in-vivo potency
Benefits
Other Benefits
- Variable component
Competitive Pay
- Global equity cash plan
Flexible Working
- Hybrid work models
- Part-time arrangements
- Flexible working arrangements
Childcare
- Company daycare centers
- Childcare support
- Children's summer camps
Family Support
- Family care leave
Learning & Development
- Learning and development opportunities
- Bayer Learning Academy training
Mentorship & Coaching
- Development dialogues
- Coaching and mentoring
Healthcare & Fitness
- Free health checks
Informal Culture
- Inclusive work environment
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?
- LGC Group
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