Merck & Co., Inc.
Sr Director Drug Substance Facility Lead(m/w/x)
Vollzeitnur vor OrtManagement
Luzern
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MEMerck & Co., Inc., Rahway, NJ, USA
Responsible Person Dir Quality Assurance(m/w/x)
Werthenstein
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Site batch release and certification for biological agents and clinical trial products. Previous Responsible Person experience and Life Science degree required. Support for regulatory inspections (Swissmedic).
Anforderungen
- Bachelor’s degree in Life Science
- Eligible as Responsible Person per I-SMI.TI.17
- Previous Responsible Person experience
- Strong Quality enterprise systems experience
- Experience supporting regulatory inspections (Swissmedic)
- Cross-functional teamwork, collaboration, influencing, negotiation skills
- Effective communication skills (oral and written)
- Strong project management skills and experience
- Auditing
- Change Management
- Client Relationship Building
- Creativity
- Cross-Cultural Awareness
- Diversity Programs
- Leadership
- Mentoring Staff
- People Leadership
- Pharmacovigilance
- Policy Implementation
- Process Improvements
- Quality Assurance (QA)
- Quality Assurance Systems
- Quality Investigations
- Quality Systems Compliance
- Regulatory Compliance
- Risk Management
Aufgaben
- Act as Responsible Person for site batch release
- Execute batch record reviews and certification
- Provide Responsible Person input for deviations
- Support batch disposition QMS topics
- Support material review and disposition
- Oversee site internal audit program
- Perform for-cause audits
- Review and approve CAPA responses
- Verify CAPA effectiveness
- Lead audits and mentor site auditors
- Host guest auditors from other sites
- Audit other company sites
- Mentor auditors on compliance skills
- Review and approve audit reports
- Lead initiatives for audits and CAPA
- Manage major change notifications to health authorities
- Approve technical and quality agreements
- Perform risk communication for management
- Provide quality oversight for deviations
- Approve change controls and complaints
- Communicate with functional areas
- Resolve comments and issues during reviews
- Identify compliance gaps
- Implement recommendations for improvement
- Maintain compliance, efficiency, and accuracy
- Stay updated on cGMP requirements
- Represent department on cross-functional teams
- Ensure permanent inspection readiness
- Develop and maintain business processes
- Provide expert technical knowledge
- Perform additional assigned activities
- Provide first-line issue resolution for the team
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- LIMS
- SAP-Quality
- MES
- Veeva Q-Docs
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Merck & Co., Inc., Rahway, NJ, USA 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?
- B. Braun Medical AG
Qualification & Validation Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenSempach - Rommelag CDMO Switzerland AG
Teamleiter-Assistenz Produktherstellung(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZell (LU) - BACHMANN FORMING AG
Fachverantwortlicher Qualitätsmanagement(m/w/x)
Vollzeitnur vor OrtJuniorHochdorf - Saab Bofors Dynamics Switzerland Ltd
Qualitätsprüfer Produktion(m/w/x)
Vollzeitnur vor OrtBerufserfahrenSarnen
MEMerck & Co., Inc., Rahway, NJ, USA
Responsible Person Dir Quality Assurance(m/w/x)
Werthenstein
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Site batch release and certification for biological agents and clinical trial products. Previous Responsible Person experience and Life Science degree required. Support for regulatory inspections (Swissmedic).
Anforderungen
- Bachelor’s degree in Life Science
- Eligible as Responsible Person per I-SMI.TI.17
- Previous Responsible Person experience
- Strong Quality enterprise systems experience
- Experience supporting regulatory inspections (Swissmedic)
- Cross-functional teamwork, collaboration, influencing, negotiation skills
- Effective communication skills (oral and written)
- Strong project management skills and experience
- Auditing
- Change Management
- Client Relationship Building
- Creativity
- Cross-Cultural Awareness
- Diversity Programs
- Leadership
- Mentoring Staff
- People Leadership
- Pharmacovigilance
- Policy Implementation
- Process Improvements
- Quality Assurance (QA)
- Quality Assurance Systems
- Quality Investigations
- Quality Systems Compliance
- Regulatory Compliance
- Risk Management
Aufgaben
- Act as Responsible Person for site batch release
- Execute batch record reviews and certification
- Provide Responsible Person input for deviations
- Support batch disposition QMS topics
- Support material review and disposition
- Oversee site internal audit program
- Perform for-cause audits
- Review and approve CAPA responses
- Verify CAPA effectiveness
- Lead audits and mentor site auditors
- Host guest auditors from other sites
- Audit other company sites
- Mentor auditors on compliance skills
- Review and approve audit reports
- Lead initiatives for audits and CAPA
- Manage major change notifications to health authorities
- Approve technical and quality agreements
- Perform risk communication for management
- Provide quality oversight for deviations
- Approve change controls and complaints
- Communicate with functional areas
- Resolve comments and issues during reviews
- Identify compliance gaps
- Implement recommendations for improvement
- Maintain compliance, efficiency, and accuracy
- Stay updated on cGMP requirements
- Represent department on cross-functional teams
- Ensure permanent inspection readiness
- Develop and maintain business processes
- Provide expert technical knowledge
- Perform additional assigned activities
- Provide first-line issue resolution for the team
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- LIMS
- SAP-Quality
- MES
- Veeva Q-Docs
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Merck & Co., Inc., Rahway, NJ, USA 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
Merck & Co., Inc., Rahway, NJ, USA
Branche
Pharmaceuticals
Beschreibung
Merck & Co., Inc. is a global biopharmaceutical company committed to discovering, developing, manufacturing, and marketing a broad range of innovative health care products.
Noch nicht perfekt?
- Merck & Co., Inc.
Sr Director Drug Substance Facility Lead(m/w/x)
Vollzeitnur vor OrtManagementLuzern - B. Braun Medical AG
Qualification & Validation Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenSempach - Rommelag CDMO Switzerland AG
Teamleiter-Assistenz Produktherstellung(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZell (LU) - BACHMANN FORMING AG
Fachverantwortlicher Qualitätsmanagement(m/w/x)
Vollzeitnur vor OrtJuniorHochdorf - Saab Bofors Dynamics Switzerland Ltd
Qualitätsprüfer Produktion(m/w/x)
Vollzeitnur vor OrtBerufserfahrenSarnen