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 Global Quality Excellence and Oversight(m/w/x)
München
Full-timeOn-siteSenior
Nejo AI Summary
Developing global Quality Management Review and GxP-compliant change processes for a biotechnology firm. Extensive GxP compliance and regulatory experience required. Flexible hours, vacation account, digital learning.
Requirements
- Degree in Life Sciences, Pharmacy, Chemistry, or related field
- Advanced degrees (MSc, PhD, MBA) are a plus
- Extensive experience in Quality Assurance
- Extensive experience in GxP compliance
- Extensive experience in regulatory environments (pharmaceutical industry)
- Proven track record leading large-scale change projects
- Proven track record leading large-scale transformation projects
- Strong strategic leadership capabilities
- Ability to inspire cross-functional teams
- Ability to guide cross-functional teams (global and site-specific)
- In-depth knowledge of GMP
- In-depth knowledge of QMS
- In-depth knowledge of GxP regulations
- Experience with Change Management processes
- Exceptional problem-solving skills
- Exceptional analytical skills
- Ability to manage complex projects
- Ability to drive data-driven decision-making
- Excellent communication skills
- Excellent interpersonal skills
- Ability to collaborate effectively with stakeholders
- Hands-on approach
- Ability to navigate strategic challenges
- Ability to navigate dynamic environments
- Ability to navigate fast-paced environments
Tasks
- Lead global Quality Management Review development
- Implement comprehensive Quality Management Systems
- Drive GxP-compliant Change Management processes
- Conduct detailed strategic and tactical progress reviews
- Collaborate with site and global leaders on milestones
- Ensure alignment with regulatory and organizational goals
- Manage processes impacting patient safety and product quality
- Ensure GxP regulatory compliance
- Enhance quality standards on business and GxP levels
- Support ongoing GxP and Quality Assurance initiatives
- Combine strategic oversight with hands-on contributions
- Ensure 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
- LinkedIn Learning
Career Advancement
- Performance and talent development
- Leadership development
Other Benefits
- Apprenticeships
- Support for your full potential
Startup Environment
- Voice at the table
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape and 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.
Not a perfect match?
- Apellis
Senior Director, General Manager(m/w/x)
Full-timeOn-siteSeniorMünchen - Merck & Co., Inc., Rahway, NJ, USA
Qualified Person als Quality Operations Group Lead Compliance(m/w/x)
Full-timeOn-siteManagementMünchen - HERMES ARZNEIMITTEL GmbH
Leitung Qualitätssicherung(m/w/x)
Full-timeTemporary contractOn-siteSeniorPullach im Isartal
BIBioNTech SE
Senior Director Global Quality Excellence and Oversight(m/w/x)
München
Full-timeOn-siteSenior
Nejo AI Summary
Developing global Quality Management Review and GxP-compliant change processes for a biotechnology firm. Extensive GxP compliance and regulatory experience required. Flexible hours, vacation account, digital learning.
Requirements
- Degree in Life Sciences, Pharmacy, Chemistry, or related field
- Advanced degrees (MSc, PhD, MBA) are a plus
- Extensive experience in Quality Assurance
- Extensive experience in GxP compliance
- Extensive experience in regulatory environments (pharmaceutical industry)
- Proven track record leading large-scale change projects
- Proven track record leading large-scale transformation projects
- Strong strategic leadership capabilities
- Ability to inspire cross-functional teams
- Ability to guide cross-functional teams (global and site-specific)
- In-depth knowledge of GMP
- In-depth knowledge of QMS
- In-depth knowledge of GxP regulations
- Experience with Change Management processes
- Exceptional problem-solving skills
- Exceptional analytical skills
- Ability to manage complex projects
- Ability to drive data-driven decision-making
- Excellent communication skills
- Excellent interpersonal skills
- Ability to collaborate effectively with stakeholders
- Hands-on approach
- Ability to navigate strategic challenges
- Ability to navigate dynamic environments
- Ability to navigate fast-paced environments
Tasks
- Lead global Quality Management Review development
- Implement comprehensive Quality Management Systems
- Drive GxP-compliant Change Management processes
- Conduct detailed strategic and tactical progress reviews
- Collaborate with site and global leaders on milestones
- Ensure alignment with regulatory and organizational goals
- Manage processes impacting patient safety and product quality
- Ensure GxP regulatory compliance
- Enhance quality standards on business and GxP levels
- Support ongoing GxP and Quality Assurance initiatives
- Combine strategic oversight with hands-on contributions
- Ensure 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
- LinkedIn Learning
Career Advancement
- Performance and talent development
- Leadership development
Other Benefits
- Apprenticeships
- Support for your full potential
Startup Environment
- Voice at the table
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape and 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., Rahway, NJ, USA
Qualified Person als Quality Operations Group Lead Compliance(m/w/x)
Full-timeOn-siteManagementMünchen - HERMES ARZNEIMITTEL GmbH
Leitung Qualitätssicherung(m/w/x)
Full-timeTemporary contractOn-siteSeniorPullach im Isartal