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Functional Lead Quality Control Services(m/w/x)
Leading a team of five for cGMP-compliant stability studies and sample logistics. Pharmaceutical industry experience with stability studies and matrix leadership required. Flexible work models, company daycare centers.
Requirements
- Bachelor's or Master's degree in pharmacy, chemistry, or natural sciences
- Several years of professional experience in pharmaceutical industry
- Experience in quality control or interface area
- Experience in stability studies
- Experience in leading matrix organizations
- Solid knowledge of cGMP
- Solid knowledge of international regulatory requirements
- Solid knowledge of pharmaceutical standards
- Knowledge regarding stability and sample logistics
- Experience using software programs
- Ability to foster trusting environment
- Open communication
- Effective teamwork
- Strong analytical thinking skills
- Strong problem-solving skills
- Clarity in decision-making
- High commitment
- Ability to work under pressure
- Excellent written German skills
- Excellent verbal German skills
- Excellent written English skills
- Excellent verbal English skills
Tasks
- Functionally lead a team of five
- Ensure cGMP-compliant processes for stability studies
- Ensure cGMP-compliant processes for sample logistics
- Plan stability studies for the site
- Coordinate stability studies for the site
- Ensure stability studies for the site
- Plan stability studies for transfers
- Coordinate stability studies for transfers
- Ensure stability studies for transfers
- Plan stability studies for launches
- Coordinate stability studies for launches
- Ensure stability studies for launches
- Approve stability study results
- Evaluate stability study results
- Determine product stability profiles
- Confirm product stability profiles
- Determine product shelf life
- Confirm product shelf life
- Ensure CMC documents are created
- Ensure CMC documents are updated
- Guarantee life cycle management of technical equipment
- Ensure GMP-compliant sample logistics
- Ensure timely sample logistics
- Represent the area in project teams
- Represent the area in product teams
- Represent the area in launch teams
- Represent the area in design teams
- Provide technical expertise
- Represent the area during regulatory inspections
- Represent the area during customer audits
- Support continuous improvement of QC processes
- Analyze trends in QC processes
- Evaluate KPIs for business processes
- Work across sites and clusters
- Support strategic goals
- Support compliance initiatives
- Ensure policies are met
- Ensure procedures are met
- Ensure specifications are met
- Ensure laboratory safety
- Ensure GMP compliance
- Ensure regulatory compliance
- Ensure FDA requirements are met
- Ensure professional training of employees
- Ensure continuous development of employees
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Native
- English – Native
Tools & Technologies
- SAP
- LIMS
Benefits
Flexible Working
- Flexible work models
- Part-time arrangements
Childcare
- Company daycare centers
- Childcare support
- Summer camps for children
Family Support
- Time off for family care
Learning & Development
- Learning and development opportunities
- Training programs
Mentorship & Coaching
- Development dialogues
- Coaching programs
- Mentoring programs
Healthcare & Fitness
- Health awareness promotion
- Free health checks
Mental Health Support
- Self-care opportunities
Informal Culture
- Inclusive work environment
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Functional Lead Quality Control Services(m/w/x)
Leading a team of five for cGMP-compliant stability studies and sample logistics. Pharmaceutical industry experience with stability studies and matrix leadership required. Flexible work models, company daycare centers.
Requirements
- Bachelor's or Master's degree in pharmacy, chemistry, or natural sciences
- Several years of professional experience in pharmaceutical industry
- Experience in quality control or interface area
- Experience in stability studies
- Experience in leading matrix organizations
- Solid knowledge of cGMP
- Solid knowledge of international regulatory requirements
- Solid knowledge of pharmaceutical standards
- Knowledge regarding stability and sample logistics
- Experience using software programs
- Ability to foster trusting environment
- Open communication
- Effective teamwork
- Strong analytical thinking skills
- Strong problem-solving skills
- Clarity in decision-making
- High commitment
- Ability to work under pressure
- Excellent written German skills
- Excellent verbal German skills
- Excellent written English skills
- Excellent verbal English skills
Tasks
- Functionally lead a team of five
- Ensure cGMP-compliant processes for stability studies
- Ensure cGMP-compliant processes for sample logistics
- Plan stability studies for the site
- Coordinate stability studies for the site
- Ensure stability studies for the site
- Plan stability studies for transfers
- Coordinate stability studies for transfers
- Ensure stability studies for transfers
- Plan stability studies for launches
- Coordinate stability studies for launches
- Ensure stability studies for launches
- Approve stability study results
- Evaluate stability study results
- Determine product stability profiles
- Confirm product stability profiles
- Determine product shelf life
- Confirm product shelf life
- Ensure CMC documents are created
- Ensure CMC documents are updated
- Guarantee life cycle management of technical equipment
- Ensure GMP-compliant sample logistics
- Ensure timely sample logistics
- Represent the area in project teams
- Represent the area in product teams
- Represent the area in launch teams
- Represent the area in design teams
- Provide technical expertise
- Represent the area during regulatory inspections
- Represent the area during customer audits
- Support continuous improvement of QC processes
- Analyze trends in QC processes
- Evaluate KPIs for business processes
- Work across sites and clusters
- Support strategic goals
- Support compliance initiatives
- Ensure policies are met
- Ensure procedures are met
- Ensure specifications are met
- Ensure laboratory safety
- Ensure GMP compliance
- Ensure regulatory compliance
- Ensure FDA requirements are met
- Ensure professional training of employees
- Ensure continuous development of employees
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Native
- English – Native
Tools & Technologies
- SAP
- LIMS
Benefits
Flexible Working
- Flexible work models
- Part-time arrangements
Childcare
- Company daycare centers
- Childcare support
- Summer camps for children
Family Support
- Time off for family care
Learning & Development
- Learning and development opportunities
- Training programs
Mentorship & Coaching
- Development dialogues
- Coaching programs
- Mentoring programs
Healthcare & Fitness
- Health awareness promotion
- Free health checks
Mental Health Support
- Self-care opportunities
Informal Culture
- Inclusive work environment
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?
- Bayer
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Senior Consultant SAP Quality Management (QM)(m/w/x)
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Full-timeWith HomeofficeSeniorKöln - Bayer
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