Merck & Co., Inc.
Assoc. Dir., Engineering(m/w/x)
Vollzeitnur vor OrtSenior
Luzern
Neuer Job?Nejo!
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MSMSD Animal Health GmbH
Associate Director, Animal Health, Global Quality Technical and Compliance Team(m/w/x)
Luzern
ab 82.400 / Jahr
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Internal and external GMP audits for global manufacturing facilities and equipment compliance. Degree in Engineering, Biology, or Chemistry with 5-7 years quality experience required. Flexible work arrangements, hybrid model with global travel.
Anforderungen
- Degree in Engineering, Biology, or Chemistry
- 5-7 years manufacturing or quality experience
- Subject matter expertise in regulated manufacturing
- Understanding of Quality Management Systems
- Compliance knowledge and regulatory interpretation skills
- Ability to work independently
- Excellent communication and strategic thinking skills
- Detail orientation and organizational skills
- Positive change agent and adaptability
- Ability to travel globally 25%
- Collaborative relationship management skills
- Ability to lead compliance initiatives
- Process improvement and system implementation skills
- Expertise in Quality Risk Management
- Lean Six Sigma belt or experience
- Engagement in regulatory or industry forums
- Experience with IT tools optimization
Aufgaben
- Lead internal and external GMP audits
- Ensure compliance with worldwide regulatory expectations
- Verify facilities and equipment meet requirements
- Audit personnel, organization, and procedures
- Review records, reports, and controls
- Partner with internal and external manufacturers
- Negotiate corrective actions with external firms
- Generate extensive, high-quality GMP documentation
- Collaborate with divisional oversight and commercial sites
- Perform detailed GMP compliance audits globally
- Travel worldwide approximately 25% of the time
- Conduct due diligence and pre-contract audits
- Perform Pre-PAI audits for new business
- Execute audit pre-work and planning
- Write audit reports within defined timeframes
- Maintain expertise in company policies and guidelines
- Monitor evolving industry and regulatory trends
- Complete ongoing training for auditor qualification
- Coordinate audit refusals with Site Quality leads
- Lead projects to improve audit efficiency
- Maintain expertise in Biologics and Medical Devices
- Manage compliance for Vaccines and Small Molecules
- Oversee API and Controlled Substance requirements
- Communicate critical findings to Procurement and leadership
- Generate comprehensive presentations on audit issues
- Ensure required assessments for critical findings
- Support the electronic Supplier Tracking and Repository System
- Assist in system data maintenance
Berufserfahrung
5 - 7 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
FDAEUAPIMedical DeviceBiologicsVaccinesQuality Management Systems (QMS)Lean Six Sigma (LSS)IT tools
Benefits
Flexibles Arbeiten
- •Hybrid work model
- •Flexible work arrangements
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens MSD Animal Health GmbH 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.
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MSMSD Animal Health GmbH
Associate Director, Animal Health, Global Quality Technical and Compliance Team(m/w/x)
Luzern
ab 82.400 / Jahr
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Internal and external GMP audits for global manufacturing facilities and equipment compliance. Degree in Engineering, Biology, or Chemistry with 5-7 years quality experience required. Flexible work arrangements, hybrid model with global travel.
Anforderungen
- Degree in Engineering, Biology, or Chemistry
- 5-7 years manufacturing or quality experience
- Subject matter expertise in regulated manufacturing
- Understanding of Quality Management Systems
- Compliance knowledge and regulatory interpretation skills
- Ability to work independently
- Excellent communication and strategic thinking skills
- Detail orientation and organizational skills
- Positive change agent and adaptability
- Ability to travel globally 25%
- Collaborative relationship management skills
- Ability to lead compliance initiatives
- Process improvement and system implementation skills
- Expertise in Quality Risk Management
- Lean Six Sigma belt or experience
- Engagement in regulatory or industry forums
- Experience with IT tools optimization
Aufgaben
- Lead internal and external GMP audits
- Ensure compliance with worldwide regulatory expectations
- Verify facilities and equipment meet requirements
- Audit personnel, organization, and procedures
- Review records, reports, and controls
- Partner with internal and external manufacturers
- Negotiate corrective actions with external firms
- Generate extensive, high-quality GMP documentation
- Collaborate with divisional oversight and commercial sites
- Perform detailed GMP compliance audits globally
- Travel worldwide approximately 25% of the time
- Conduct due diligence and pre-contract audits
- Perform Pre-PAI audits for new business
- Execute audit pre-work and planning
- Write audit reports within defined timeframes
- Maintain expertise in company policies and guidelines
- Monitor evolving industry and regulatory trends
- Complete ongoing training for auditor qualification
- Coordinate audit refusals with Site Quality leads
- Lead projects to improve audit efficiency
- Maintain expertise in Biologics and Medical Devices
- Manage compliance for Vaccines and Small Molecules
- Oversee API and Controlled Substance requirements
- Communicate critical findings to Procurement and leadership
- Generate comprehensive presentations on audit issues
- Ensure required assessments for critical findings
- Support the electronic Supplier Tracking and Repository System
- Assist in system data maintenance
Berufserfahrung
5 - 7 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
FDAEUAPIMedical DeviceBiologicsVaccinesQuality Management Systems (QMS)Lean Six Sigma (LSS)IT tools
Benefits
Flexibles Arbeiten
- •Hybrid work model
- •Flexible work arrangements
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens MSD Animal Health GmbH 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
MSD Animal Health GmbH
Branche
Pharmaceuticals
Beschreibung
The company embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds to drive innovation.
Noch nicht perfekt?
- Merck & Co., Inc.
Assoc. Dir., Engineering(m/w/x)
Vollzeitnur vor OrtSeniorLuzern - Merck & Co., Inc.
Sr Director Drug Substance Facility Lead(m/w/x)
Vollzeitnur vor OrtManagementLuzern - Sanofi International AG
Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Senior Scientist PMQ(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz