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Head of Quality & GMP Operations(m/w/x)
Directing QMS development and regulatory compliance for pharmaceutical and biotech client medicine development. Proven leadership in quality system optimization and aseptic processing knowledge required. Flexible working arrangements.
Anforderungen
- Proven experience in a GMP-regulated environment
- Leadership in building, optimizing, or remediating Quality Management Systems (QMS)
- Strong track record managing end-to-end quality processes
- Deep understanding of aseptic processing principles
- Exceptional leadership skills
- Ability to build and foster a strong quality culture
- Strong experience working closely with manufacturing, tech ops, and supply chain teams
- Excellent communication, negotiation, and influence skills
- Strategic thinker with a pragmatic approach to problem-solving
- Strong analytical skills for data-driven decisions
Aufgaben
- Lead the development and optimization of Quality Management Systems (QMS)
- Ensure compliance with global GMP regulations (FDA, EMA, ICH)
- Manage core quality processes including deviations and CAPAs
- Oversee change control and document management
- Maintain comprehensive audit readiness
- Apply aseptic processing principles and contamination control strategies
- Drive cultural and operational transformation initiatives
- Foster a strong quality culture in a fast-paced environment
- Ensure accountability for quality across cross-functional teams
- Integrate compliance goals with broader business objectives
- Mentor and develop Quality Assurance professionals
- Collaborate with manufacturing, technical operations, and supply chain teams
- Engage and communicate effectively at all organizational levels
- Lead through influence and manage resistance to change
- Streamline QA processes while maintaining compliance
- Make data-driven decisions and apply risk management principles
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Betriebliche Altersvorsorge
- Competitive pension fund plan
Boni & Prämien
- Annual bonus
Flexibles Arbeiten
- Flexible working arrangements
Lockere Unternehmenskultur
- Open culture
- Diverse workforce
Karriere- und Weiterentwicklung
- Career development opportunity
Weiterbildungsangebote
- Wide range of training options
Noch nicht perfekt?
- LonzaVollzeitnur vor OrtSeniorVisp
- Lonza
Senior QA Specialist, QA Operations(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Vaxcyte
Director, Business Operations (Global Quality Control)(m/w/x)
Vollzeitnur vor OrtManagementVisp - Lonza
Head of QA Support (Shop Floor and Batch Record Review)(m/w/x)
Vollzeitnur vor OrtManagementVisp - ten23 health
Senior QMS & Compliance Expert(m/w/x)
Vollzeitnur vor OrtSeniorVisp
Head of Quality & GMP Operations(m/w/x)
Directing QMS development and regulatory compliance for pharmaceutical and biotech client medicine development. Proven leadership in quality system optimization and aseptic processing knowledge required. Flexible working arrangements.
Anforderungen
- Proven experience in a GMP-regulated environment
- Leadership in building, optimizing, or remediating Quality Management Systems (QMS)
- Strong track record managing end-to-end quality processes
- Deep understanding of aseptic processing principles
- Exceptional leadership skills
- Ability to build and foster a strong quality culture
- Strong experience working closely with manufacturing, tech ops, and supply chain teams
- Excellent communication, negotiation, and influence skills
- Strategic thinker with a pragmatic approach to problem-solving
- Strong analytical skills for data-driven decisions
Aufgaben
- Lead the development and optimization of Quality Management Systems (QMS)
- Ensure compliance with global GMP regulations (FDA, EMA, ICH)
- Manage core quality processes including deviations and CAPAs
- Oversee change control and document management
- Maintain comprehensive audit readiness
- Apply aseptic processing principles and contamination control strategies
- Drive cultural and operational transformation initiatives
- Foster a strong quality culture in a fast-paced environment
- Ensure accountability for quality across cross-functional teams
- Integrate compliance goals with broader business objectives
- Mentor and develop Quality Assurance professionals
- Collaborate with manufacturing, technical operations, and supply chain teams
- Engage and communicate effectively at all organizational levels
- Lead through influence and manage resistance to change
- Streamline QA processes while maintaining compliance
- Make data-driven decisions and apply risk management principles
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Betriebliche Altersvorsorge
- Competitive pension fund plan
Boni & Prämien
- Annual bonus
Flexibles Arbeiten
- Flexible working arrangements
Lockere Unternehmenskultur
- Open culture
- Diverse workforce
Karriere- und Weiterentwicklung
- Career development opportunity
Weiterbildungsangebote
- Wide range of training options
Über das Unternehmen
ten23 health
Branche
Pharmaceuticals
Beschreibung
The company is a human-centric strategic partner for the pharmaceutical industry and biotech start-ups, focusing on the development and testing of medicines.
Noch nicht perfekt?
- Lonza
Head of QA Mammalian(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist, QA Operations(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Vaxcyte
Director, Business Operations (Global Quality Control)(m/w/x)
Vollzeitnur vor OrtManagementVisp - Lonza
Head of QA Support (Shop Floor and Batch Record Review)(m/w/x)
Vollzeitnur vor OrtManagementVisp - ten23 health
Senior QMS & Compliance Expert(m/w/x)
Vollzeitnur vor OrtSeniorVisp