Novartis
QA Compliance Lead(m/w/x)
Full-timeOn-siteSenior
Stein
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Leading GMP compliance and inspection readiness for a global medicines company. Minimum 15 years QA/Compliance experience in pharma/biotech required. Reasonable accommodation for medical conditions.
Requirements
- Minimum 15 years progressive experience in QA and Compliance in GMP-regulated pharma/biotech
- Proven track record in senior QA leadership roles
- Deep expertise in cGMP, Quality Systems, and regulatory frameworks (EMA, FDA, Swissmedic)
- Extensive experience leading health authority inspections, audits, and remediation
- Strong credibility and executive presence with stakeholders
- Demonstrated ability to lead, influence, and challenge senior management
- University degree in Life Sciences, Pharmacy, Chemistry, or Biotechnology
- Fluent English; German is a strong advantage
Tasks
- Lead Quality Compliance activities
- Ensure GMP compliance
- Act as senior quality authority for audits
- Maintain inspection readiness
- Develop Quality Management System
- Manage deviations, CAPAs, change control
- Ensure data integrity
- Govern GxP risk management
- Manage compliance remediation
- Oversee regulatory and quality activities
- Monitor suppliers and service providers
- Promote quality culture
- Model integrity and accountability
- Partner with senior stakeholders
- Coach senior quality professionals
- Develop sustainable expertise
- Champion Lean Leadership
- Drive operational excellence
Work Experience
- 15 years
Education
- Bachelor's degree
Languages
- English – Fluent
Benefits
Other Benefits
- Reasonable accommodation for medical condition or disability
Mentorship & Coaching
- Handbook for personal and professional thriving
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis 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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Leading GMP compliance and inspection readiness for a global medicines company. Minimum 15 years QA/Compliance experience in pharma/biotech required. Reasonable accommodation for medical conditions.
Requirements
- Minimum 15 years progressive experience in QA and Compliance in GMP-regulated pharma/biotech
- Proven track record in senior QA leadership roles
- Deep expertise in cGMP, Quality Systems, and regulatory frameworks (EMA, FDA, Swissmedic)
- Extensive experience leading health authority inspections, audits, and remediation
- Strong credibility and executive presence with stakeholders
- Demonstrated ability to lead, influence, and challenge senior management
- University degree in Life Sciences, Pharmacy, Chemistry, or Biotechnology
- Fluent English; German is a strong advantage
Tasks
- Lead Quality Compliance activities
- Ensure GMP compliance
- Act as senior quality authority for audits
- Maintain inspection readiness
- Develop Quality Management System
- Manage deviations, CAPAs, change control
- Ensure data integrity
- Govern GxP risk management
- Manage compliance remediation
- Oversee regulatory and quality activities
- Monitor suppliers and service providers
- Promote quality culture
- Model integrity and accountability
- Partner with senior stakeholders
- Coach senior quality professionals
- Develop sustainable expertise
- Champion Lean Leadership
- Drive operational excellence
Work Experience
- 15 years
Education
- Bachelor's degree
Languages
- English – Fluent
Benefits
Other Benefits
- Reasonable accommodation for medical condition or disability
Mentorship & Coaching
- Handbook for personal and professional thriving
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Novartis
Industry
Pharmaceuticals
Description
Novartis is an innovative medicines company focused on reimagining medicine to improve and extend people's lives and empower patients, healthcare professionals, and societies.
Not a perfect match?
- Novartis
QA Compliance Lead(m/w/x)
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Head of QA for QC(m/w/x)
Full-timeOn-siteSeniorKaiseraugst - Roche
Head of Compliance and Quality Governance(m/w/x)
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Head IMP Quality Clinical Packaging KAU(m/w/x)
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