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BP Regulatory Affairs Manager(m/w/x)
At a life-science company, authoring GxP documentation and training for pharmaceutical manufacturing, ensuring GMP customer alignment. Solid quality background with core GxP systems and pharma manufacturing experience required. Thirty vacation days, working time account, remote work across Germany.
Requirements
- Degree in natural science, biotechnology, or comparable
- Solid quality background with core GxP systems
- Professional experience in quality or regulatory in pharma manufacturing
- Professional experience with quality tools in pharmaceutical industry
- Excellent communication skills in German and English
- Accurate and detail-oriented mindset
- Highly skilled in Microsoft Office applications
- Passionated and motivating attitude
Tasks
- Author and maintain internal guidance and training documentation
- Collaborate with global functions, suppliers, and customers to share expertise
- Review documents for alignment with GMP customer expectations
- Provide targeted training sessions and participate in global presentations
- Work closely with the Quality team to align on quality systems
- Support colleagues in implementing requirements and translating them into solutions
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- GxP systems
- Computer software validation (CSV)
- Equipment qualification (IQ/OQ)
- Process Validation
Benefits
More Vacation Days
- Thirty vacation days per year
- Company-regulated special leave days
Flexible Working
- Flexible flextime framework
- Working time account
- Remote work across Germany
Retirement Plans
- Employer-funded retirement plans
Company Bike
- Job bike
Public Transport Subsidies
- Public transport subsidies
Corporate Discounts
- Corporate benefits
Learning & Development
- Freely selectable training sessions
- Participation in conferences
- Access to learning platforms
Informal Culture
- Diverse and open-minded work environment
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BP Regulatory Affairs Manager(m/w/x)
At a life-science company, authoring GxP documentation and training for pharmaceutical manufacturing, ensuring GMP customer alignment. Solid quality background with core GxP systems and pharma manufacturing experience required. Thirty vacation days, working time account, remote work across Germany.
Requirements
- Degree in natural science, biotechnology, or comparable
- Solid quality background with core GxP systems
- Professional experience in quality or regulatory in pharma manufacturing
- Professional experience with quality tools in pharmaceutical industry
- Excellent communication skills in German and English
- Accurate and detail-oriented mindset
- Highly skilled in Microsoft Office applications
- Passionated and motivating attitude
Tasks
- Author and maintain internal guidance and training documentation
- Collaborate with global functions, suppliers, and customers to share expertise
- Review documents for alignment with GMP customer expectations
- Provide targeted training sessions and participate in global presentations
- Work closely with the Quality team to align on quality systems
- Support colleagues in implementing requirements and translating them into solutions
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- GxP systems
- Computer software validation (CSV)
- Equipment qualification (IQ/OQ)
- Process Validation
Benefits
More Vacation Days
- Thirty vacation days per year
- Company-regulated special leave days
Flexible Working
- Flexible flextime framework
- Working time account
- Remote work across Germany
Retirement Plans
- Employer-funded retirement plans
Company Bike
- Job bike
Public Transport Subsidies
- Public transport subsidies
Corporate Discounts
- Corporate benefits
Learning & Development
- Freely selectable training sessions
- Participation in conferences
- Access to learning platforms
Informal Culture
- Diverse and open-minded work environment
About the Company
DASGIP Information and Process Technology GmbH
Industry
Other
Description
Das Unternehmen bietet Gestaltungsspielraum in der Life-Science Branche und fördert ein wertschätzendes Arbeitsumfeld.
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