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Manager Quality & Partner Management(m/w/x)
Managing GMP/GDP Quality Agreement lifecycles for rare disease and critical care therapies. 5+ years in regulated pharmaceutical GxP environment with proven GMP/GDP Quality Agreement negotiation experience required. Unique time-out days benefit.
Requirements
- University degree in Life Sciences, Pharmacy, Chemistry or related field
- 5+ years experience in regulated pharmaceutical GxP environment
- Solid understanding of pharmaceutical quality management systems
- Proven experience negotiating and managing GMP/GDP Quality Agreements
- Highly desirable experience conducting GxP audits
- Strong analytical thinking and structured, detail-oriented working style
- Open-minded personality; pro-active attitude; problem-solving approach
- Excellent planning, communication, presentation skills; team-oriented mindset; cross-department collaboration ability
- Strong MS Office (Office 365) skills
- University degree in Life Sciences, Pharmacy, Chemistry or related field
- 5+ years experience in regulated pharmaceutical GxP environment
- Solid understanding of pharmaceutical quality management systems
- Proven experience negotiating and managing GMP/GDP Quality Agreements
- Highly desirable experience conducting GxP audits
- Strong analytical thinking and structured, detail-oriented working style
- Open-minded personality; pro-active attitude; problem-solving approach
- Excellent planning, communication, presentation skills; team-oriented mindset; cross-department collaboration ability
- Strong MS Office (Office 365) skills
Tasks
- Serve as a central interface for internal and global partners
- Safeguard quality and regulatory compliance across the product lifecycle
- Negotiate GMP/GDP Quality Agreements
- Establish GMP/GDP Quality Agreements
- Manage GMP/GDP Quality Agreement lifecycles
- Support qualification and re-qualification of partners
- Maintain and approve product and production data in ERP and serialisation systems
- Communicate cross-functionally with Commercial, Supply Chain, and Regulatory
- Lead and conduct GMP/GDP audits at external partners
- Ensure effective CAPA follow-up
- Contribute to multidisciplinary project teams
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
- Office 365
Benefits
Flexible Working
- Flexible working hours
- Flexitime
- Home office
More Vacation Days
- Time-out days
Bonuses & Incentives
- Bonus scheme
- Bonus
Team Events
- Employee events
Mentorship & Coaching
- Structured onboarding
- Buddy system support
Modern Equipment
- Employee mobile phone
- Laptop
Learning & Development
- Initial and continuing education
Free or Subsidized Food
- Canteen
Parking & Commuter Benefits
- Good transport connection
- Parking spot
Additional Allowances
- Meal allowance
Healthcare & Fitness
- Company doctor
- Health measures
Corporate Discounts
- Employee discount
Company Vehicle
- Company car
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Manager Quality & Partner Management(m/w/x)
Managing GMP/GDP Quality Agreement lifecycles for rare disease and critical care therapies. 5+ years in regulated pharmaceutical GxP environment with proven GMP/GDP Quality Agreement negotiation experience required. Unique time-out days benefit.
Requirements
- University degree in Life Sciences, Pharmacy, Chemistry or related field
- 5+ years experience in regulated pharmaceutical GxP environment
- Solid understanding of pharmaceutical quality management systems
- Proven experience negotiating and managing GMP/GDP Quality Agreements
- Highly desirable experience conducting GxP audits
- Strong analytical thinking and structured, detail-oriented working style
- Open-minded personality; pro-active attitude; problem-solving approach
- Excellent planning, communication, presentation skills; team-oriented mindset; cross-department collaboration ability
- Strong MS Office (Office 365) skills
- University degree in Life Sciences, Pharmacy, Chemistry or related field
- 5+ years experience in regulated pharmaceutical GxP environment
- Solid understanding of pharmaceutical quality management systems
- Proven experience negotiating and managing GMP/GDP Quality Agreements
- Highly desirable experience conducting GxP audits
- Strong analytical thinking and structured, detail-oriented working style
- Open-minded personality; pro-active attitude; problem-solving approach
- Excellent planning, communication, presentation skills; team-oriented mindset; cross-department collaboration ability
- Strong MS Office (Office 365) skills
Tasks
- Serve as a central interface for internal and global partners
- Safeguard quality and regulatory compliance across the product lifecycle
- Negotiate GMP/GDP Quality Agreements
- Establish GMP/GDP Quality Agreements
- Manage GMP/GDP Quality Agreement lifecycles
- Support qualification and re-qualification of partners
- Maintain and approve product and production data in ERP and serialisation systems
- Communicate cross-functionally with Commercial, Supply Chain, and Regulatory
- Lead and conduct GMP/GDP audits at external partners
- Ensure effective CAPA follow-up
- Contribute to multidisciplinary project teams
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
- Office 365
Benefits
Flexible Working
- Flexible working hours
- Flexitime
- Home office
More Vacation Days
- Time-out days
Bonuses & Incentives
- Bonus scheme
- Bonus
Team Events
- Employee events
Mentorship & Coaching
- Structured onboarding
- Buddy system support
Modern Equipment
- Employee mobile phone
- Laptop
Learning & Development
- Initial and continuing education
Free or Subsidized Food
- Canteen
Parking & Commuter Benefits
- Good transport connection
- Parking spot
Additional Allowances
- Meal allowance
Healthcare & Fitness
- Company doctor
- Health measures
Corporate Discounts
- Employee discount
Company Vehicle
- Company car
About the Company
AOP Health
Industry
Pharmaceuticals
Description
AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care.
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