ten23 health
Senior QMS & Compliance Expert(m/w/x)
Vollzeitnur vor OrtSenior
Visp
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
TEten23 health
Supplier Quality, QMS and Compliance Expert(m/w/x)
Visp
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Supplier quality management and QMS improvement for injectable medicine development. 7+ years QA experience in pharma/biotech with global regulatory framework knowledge required. Flexible working arrangements, diverse workforce.
Anforderungen
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or related scientific discipline
- 7+ years progressive experience in Quality Assurance (pharmaceutical, biotech, medical device industry) with focus on Supplier Quality Management
- Deep, practical knowledge of global regulatory frameworks (cGMP, EudraLex Vol 4, ICH Q8/Q9/Q10, FDA regulations)
- Extensive experience planning, leading, and executing external supplier audits
- Lead Auditor Certification (ISO 9001, ASQ CQA) highly desirable
- Proven track record managing/optimizing QMS elements (Deviations, CAPAs, Change Controls)
- Authoring complex, legally binding Quality Agreements
- Fluent in English
- Additional languages a plus for global supplier interactions
- Willingness to travel for on-site supplier qualification visits and audits
Aufgaben
- Lead Supplier Quality Management and Quality Systems activities
- Ensure effective supplier qualification and lifecycle management
- Support maintenance and improvement of the pharmaceutical QMS
- Act as key contact for internal and external stakeholders on quality and compliance
- Establish functional objectives and performance metrics for continuous improvement
- Oversee end-to-end supplier qualification and onboarding processes
- Conduct rigorous due diligence, risk assessments, and periodic evaluations
- Lead supplier audits, remote assessments, and qualification visits
- Drive timely resolution of audit observations and CAPAs
- Negotiate and manage Quality Agreements with suppliers and service providers
- Monitor supplier performance, quality events, and compliance trends
- Escalate and remediate risks immediately
- Support and improve core QMS processes
- Ensure outsourced activities comply with cGMP standards and industry guidelines
- Maintain inspection readiness and manage regulatory inspections
- Partner with Procurement, Operations, QC, Validation, and Regulatory Affairs
- Serve as primary advisor on supplier quality and compliance matters
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Benefits
Karriere- und Weiterentwicklung
- Career development opportunity
Flexibles Arbeiten
- Flexible working arrangements
- Flexibility
Lockere Unternehmenskultur
- Open culture
- Diverse workforce
- Minimal bureaucracy
Mentoring & Coaching
- Learning from experienced employees
Weiterbildungsangebote
- Wide range of training options
Betriebliche Altersvorsorge
- Competitive pension fund plan
Boni & Prämien
- Annual bonus
Sonstige Vorteile
- Other financial and non-financial benefits
- Mutual trust
Sinnstiftende Arbeit
- Self-responsibility
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ten23 health erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- Lonza
Senior QA Specialist, Supplier Management(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
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Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Senior QA Specialist(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Vaxcyte
Manager, Quality Assurance(m/w/x)
Vollzeitnur vor OrtSeniorVisp
TEten23 health
Supplier Quality, QMS and Compliance Expert(m/w/x)
Visp
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Supplier quality management and QMS improvement for injectable medicine development. 7+ years QA experience in pharma/biotech with global regulatory framework knowledge required. Flexible working arrangements, diverse workforce.
Anforderungen
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or related scientific discipline
- 7+ years progressive experience in Quality Assurance (pharmaceutical, biotech, medical device industry) with focus on Supplier Quality Management
- Deep, practical knowledge of global regulatory frameworks (cGMP, EudraLex Vol 4, ICH Q8/Q9/Q10, FDA regulations)
- Extensive experience planning, leading, and executing external supplier audits
- Lead Auditor Certification (ISO 9001, ASQ CQA) highly desirable
- Proven track record managing/optimizing QMS elements (Deviations, CAPAs, Change Controls)
- Authoring complex, legally binding Quality Agreements
- Fluent in English
- Additional languages a plus for global supplier interactions
- Willingness to travel for on-site supplier qualification visits and audits
Aufgaben
- Lead Supplier Quality Management and Quality Systems activities
- Ensure effective supplier qualification and lifecycle management
- Support maintenance and improvement of the pharmaceutical QMS
- Act as key contact for internal and external stakeholders on quality and compliance
- Establish functional objectives and performance metrics for continuous improvement
- Oversee end-to-end supplier qualification and onboarding processes
- Conduct rigorous due diligence, risk assessments, and periodic evaluations
- Lead supplier audits, remote assessments, and qualification visits
- Drive timely resolution of audit observations and CAPAs
- Negotiate and manage Quality Agreements with suppliers and service providers
- Monitor supplier performance, quality events, and compliance trends
- Escalate and remediate risks immediately
- Support and improve core QMS processes
- Ensure outsourced activities comply with cGMP standards and industry guidelines
- Maintain inspection readiness and manage regulatory inspections
- Partner with Procurement, Operations, QC, Validation, and Regulatory Affairs
- Serve as primary advisor on supplier quality and compliance matters
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Benefits
Karriere- und Weiterentwicklung
- Career development opportunity
Flexibles Arbeiten
- Flexible working arrangements
- Flexibility
Lockere Unternehmenskultur
- Open culture
- Diverse workforce
- Minimal bureaucracy
Mentoring & Coaching
- Learning from experienced employees
Weiterbildungsangebote
- Wide range of training options
Betriebliche Altersvorsorge
- Competitive pension fund plan
Boni & Prämien
- Annual bonus
Sonstige Vorteile
- Other financial and non-financial benefits
- Mutual trust
Sinnstiftende Arbeit
- Self-responsibility
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ten23 health erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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?
- ten23 health
Senior QMS & Compliance Expert(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist, Supplier Management(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist/QA Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Senior QA Specialist(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Vaxcyte
Manager, Quality Assurance(m/w/x)
Vollzeitnur vor OrtSeniorVisp