Merck & Co., Inc.
Qualified Person als Quality Operations Group Lead Compliance(m/w/x)
Full-timeOn-siteManagement
Unterschleißheim
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BIBioNTech SE
Senior Director Quality Transformation and Oversight(m/w/x)
München
Full-timeOn-siteSenior
Nejo AI Summary
Overseeing GxP-compliant QMS change management for novel drug development. Extensive GxP QA and regulatory experience with large-scale change leadership required. Flexible hours, vacation account.
Requirements
- Degree in Life Sciences, Pharmacy, Chemistry, or related field
- Extensive experience in Quality Assurance, GxP compliance, and regulatory environments
- Proven track record of leading large-scale change and transformation projects
- Strong strategic leadership capabilities
- In-depth knowledge of GMP, QMS, and GxP regulations
- Exceptional problem-solving and analytical skills
- Excellent communication and interpersonal skills
- Hands-on approach with ability to navigate strategic challenges
Tasks
- Lead critical change and transformation projects
- Develop and implement a global Quality Management Review process
- Drive Quality Management Systems (QMS) and GxP-compliant Change Management processes
- Conduct detailed reviews of strategic and tactical progress
- Collaborate with site and global leaders to ensure alignment with priorities
- Manage key processes impacting patient safety and product quality
- Ensure compliance with GxP regulations
- Drive initiatives to enhance quality standards
- Provide strategic leadership for ongoing GxP and Quality Assurance initiatives
- Support impactful outcomes and successful project execution
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital learning
- Apprenticeships
- LinkedIn Learning
Career Advancement
- Performance development
- Leadership development
Other Benefits
- Your voice at the table
- Support for your full potential
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape & impact
Company Bike
- Company bike
Public Transport Subsidies
- Job ticket
- Deutschlandticket
Retirement Plans
- Employer-funded pension
Childcare
- Childcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE 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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- Apellis
Senior Director, General Manager(m/w/x)
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Qualified Person als Quality Operations Group Lead Documentation(m/w/x)
Full-timeTemporary contractOn-siteSeniorUnterschleißheim - HERMES ARZNEIMITTEL GmbH
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Full-timeTemporary contractOn-siteSeniorPullach im Isartal - Merck & Co., Inc., Rahway, NJ, USA
Qualified Person als Quality Operations Group Lead Compliance(m/w/x)
Full-timeOn-siteManagementMünchen
BIBioNTech SE
Senior Director Quality Transformation and Oversight(m/w/x)
München
Full-timeOn-siteSenior
Nejo AI Summary
Overseeing GxP-compliant QMS change management for novel drug development. Extensive GxP QA and regulatory experience with large-scale change leadership required. Flexible hours, vacation account.
Requirements
- Degree in Life Sciences, Pharmacy, Chemistry, or related field
- Extensive experience in Quality Assurance, GxP compliance, and regulatory environments
- Proven track record of leading large-scale change and transformation projects
- Strong strategic leadership capabilities
- In-depth knowledge of GMP, QMS, and GxP regulations
- Exceptional problem-solving and analytical skills
- Excellent communication and interpersonal skills
- Hands-on approach with ability to navigate strategic challenges
Tasks
- Lead critical change and transformation projects
- Develop and implement a global Quality Management Review process
- Drive Quality Management Systems (QMS) and GxP-compliant Change Management processes
- Conduct detailed reviews of strategic and tactical progress
- Collaborate with site and global leaders to ensure alignment with priorities
- Manage key processes impacting patient safety and product quality
- Ensure compliance with GxP regulations
- Drive initiatives to enhance quality standards
- Provide strategic leadership for ongoing GxP and Quality Assurance initiatives
- Support impactful outcomes and successful project execution
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital learning
- Apprenticeships
- LinkedIn Learning
Career Advancement
- Performance development
- Leadership development
Other Benefits
- Your voice at the table
- Support for your full potential
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape & impact
Company Bike
- Company bike
Public Transport Subsidies
- Job ticket
- Deutschlandticket
Retirement Plans
- Employer-funded pension
Childcare
- Childcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE 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
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
- Merck & Co., Inc.
Qualified Person als Quality Operations Group Lead Compliance(m/w/x)
Full-timeOn-siteManagementUnterschleißheim - Apellis
Senior Director, General Manager(m/w/x)
Full-timeOn-siteSeniorMünchen - Merck & Co., Inc.
Qualified Person als Quality Operations Group Lead Documentation(m/w/x)
Full-timeTemporary contractOn-siteSeniorUnterschleißheim - HERMES ARZNEIMITTEL GmbH
Leitung Qualitätssicherung(m/w/x)
Full-timeTemporary contractOn-siteSeniorPullach im Isartal - Merck & Co., Inc., Rahway, NJ, USA
Qualified Person als Quality Operations Group Lead Compliance(m/w/x)
Full-timeOn-siteManagementMünchen