Novartis Business Services GmbH
Site Quality Head(m/w/x)
Full-timeOn-siteSenior
Nürnberg, Halle (Saale), Dresden, Leipzig
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NONovartis Business Services GmbH
Site Quality Head(m/w/x)
Nürnberg, Halle (Saale), Dresden, Leipzig
Full-timeOn-siteSenior
Nejo AI Summary
Directing quality operations and GxP/cGMP compliance for pharmaceutical production. 10 years GMP pharmaceutical manufacturing experience, including 3 years in QC/QA, required. Strategic leadership for quality initiatives.
Requirements
- BS/MSc in Life Sciences or related experience
- 10 years of experience in GMP Pharmaceutical Manufacturing
- At least 3 years of relevant experience in Quality Control or Quality Assurance
- Proven track record in supporting Quality Control operations
- In-depth knowledge of cGMP and FDA regulations
- Ability to manage multiple projects with moderate resource requirements
- Highly developed management and communication skills
- Strong organizational and time management skills
- Experience in process improvement approaches
Tasks
- Provide quality assurance oversight
- Support quality operations
- Lead technical and strategic quality initiatives
- Ensure compliance with GxP standards
- Ensure compliance with cGMP requirements
- Represent site quality in cross-functional and global project teams
- Lead and support the Quality Assurance department
- Ensure team members are qualified and motivated
- Create user requirements and specifications for projects
- Liaise with stakeholders for project coordination
- Ensure facilities and equipment are safe and compliant
- Oversee project planning, construction, and qualification phases
- Create and maintain project plans to track progress
- Escalate risks related to timelines and budgets
- Manage product critical quality issues and deviations
- Ensure effective execution of investigations and CAPAs
- Review and approve compliance-related notifications
- Define and monitor Site Quality KPIs
- Establish and support the Site Quality Committee
- Coordinate Site Quality Plans and risk assessments
- Prepare and consolidate the Quality Unit budget
- Ensure adherence to health and safety procedures
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Business Services GmbH 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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NONovartis Business Services GmbH
Site Quality Head(m/w/x)
Nürnberg, Halle (Saale), Dresden, Leipzig
Full-timeOn-siteSenior
Nejo AI Summary
Directing quality operations and GxP/cGMP compliance for pharmaceutical production. 10 years GMP pharmaceutical manufacturing experience, including 3 years in QC/QA, required. Strategic leadership for quality initiatives.
Requirements
- BS/MSc in Life Sciences or related experience
- 10 years of experience in GMP Pharmaceutical Manufacturing
- At least 3 years of relevant experience in Quality Control or Quality Assurance
- Proven track record in supporting Quality Control operations
- In-depth knowledge of cGMP and FDA regulations
- Ability to manage multiple projects with moderate resource requirements
- Highly developed management and communication skills
- Strong organizational and time management skills
- Experience in process improvement approaches
Tasks
- Provide quality assurance oversight
- Support quality operations
- Lead technical and strategic quality initiatives
- Ensure compliance with GxP standards
- Ensure compliance with cGMP requirements
- Represent site quality in cross-functional and global project teams
- Lead and support the Quality Assurance department
- Ensure team members are qualified and motivated
- Create user requirements and specifications for projects
- Liaise with stakeholders for project coordination
- Ensure facilities and equipment are safe and compliant
- Oversee project planning, construction, and qualification phases
- Create and maintain project plans to track progress
- Escalate risks related to timelines and budgets
- Manage product critical quality issues and deviations
- Ensure effective execution of investigations and CAPAs
- Review and approve compliance-related notifications
- Define and monitor Site Quality KPIs
- Establish and support the Site Quality Committee
- Coordinate Site Quality Plans and risk assessments
- Prepare and consolidate the Quality Unit budget
- Ensure adherence to health and safety procedures
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Business Services GmbH 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
Novartis Business Services GmbH
Industry
Pharmaceuticals
Description
The company is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities it serves.
Not a perfect match?
- Novartis Business Services GmbH
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Full-timeOn-siteExperiencedNürnberg - Novartis Pharma AG
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Full-timeOn-siteNot specifiedNürnberg