Viatris Pharma GmbH
QA Manager(m/w/x)
Vollzeitnur vor OrtSenior
Zug
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ABAbbVie
QA Manager (FvP/Responsible Person)(m/w/x)
Cham
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Technical supervision of pharmaceutical product activities for innovative medicines. Good Distribution Practice (GDP) experience required. Management experience preferred.
Anforderungen
- Degree in Chemistry, Pharmacy, Biology, technical/scientific area, MBA or M.S.
- Minimum 5 years experience in quality assurance, operations, or relevant areas
- Proven prior experience in Good Distribution Practice (GDP)
- Management experience preferred
- Full understanding of local GxP requirements
- In-depth knowledge of some GxP elements
- General knowledge of AbbVie MD products and regulations
- General knowledge of pharmaceutical products and regulations
- General knowledge of biologic products and regulations
- General knowledge of cosmetic products and regulations
- Knowledge of product supply and therapeutic uses
- Understanding of strategic importance for the business
- Knowledge of product requirements
- Knowledge of process requirements
- Knowledge of internal customer requirements
- Knowledge of external customer requirements
- Knowledge of regulations
- Necessary professional training for FvP responsibility
- Sufficient experience for FvP responsibility accepted by authorities
- Ability to coach and develop others
- Investing in people
- Amplifying strengths to build talent
- Decision making with minimal direction
- Excellence focus
- Driving results through prioritization
- Driving results through continuous improvement
- Influencing stakeholders
- Shaping communication
- Negotiating to win
- Motivating teams
- Building relationships
- Inspiring followership
- Business Acumen
- Understanding QA connection to business objectives
- Embracing change
- Promoting change
- Driving change
- Excellent written communication skills
- Excellent oral communication skills
Aufgaben
- Provide leadership and oversight of Quality Compliance matters
- Ensure technical supervision of operations
- Guarantee safety, efficacy, and quality of medicines
- Handle pharmaceutical product activities
- Comply with Swiss law on Medicinal Products and AbbVie policies
- Manage storage and distribution activities
- Handle product complaints and quality events
- Conduct supplier controls and product quality reviews
- Manage risk and agency inspections
- Implement and maintain Quality Management System
- Ensure compliance with Good Distribution Practice
- Monitor controlled temperature and cold chain shipments
- Represent QA in regional and global teams
- Ensure medicinal products meet approved specifications
- Release commercial products for the Swiss market
- Decide on batch release and distribution
- Manage quality and compliance risks
- Approve SOPs and controlled documents
- Authorize return to saleable stock or destruction
- Approve Technical/Quality Agreements
- Audit external service providers
- Perform Product Quality Review
- Manage product recalls
- Handle product quality complaints
- Report quality issues to Swissmedic
- Manage quality issues with suppliers and manufacturers
- Stay updated with Swiss regulatory requirements
- Disseminate applicable regulations to stakeholders
- Act as contact person for Quality issues
- Plan and perform internal audits
- Report Site Quality Compliance Metrics
- Ensure GDP refresher training for employees
- Participate in GMP/GDP courses annually
- Assess and delegate responsibilities to Deputy FvP
Berufserfahrung
- 5 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- SAP
- TrackWise
- ComplianceWire
- OneVault
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AbbVie 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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ABAbbVie
QA Manager (FvP/Responsible Person)(m/w/x)
Cham
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Technical supervision of pharmaceutical product activities for innovative medicines. Good Distribution Practice (GDP) experience required. Management experience preferred.
Anforderungen
- Degree in Chemistry, Pharmacy, Biology, technical/scientific area, MBA or M.S.
- Minimum 5 years experience in quality assurance, operations, or relevant areas
- Proven prior experience in Good Distribution Practice (GDP)
- Management experience preferred
- Full understanding of local GxP requirements
- In-depth knowledge of some GxP elements
- General knowledge of AbbVie MD products and regulations
- General knowledge of pharmaceutical products and regulations
- General knowledge of biologic products and regulations
- General knowledge of cosmetic products and regulations
- Knowledge of product supply and therapeutic uses
- Understanding of strategic importance for the business
- Knowledge of product requirements
- Knowledge of process requirements
- Knowledge of internal customer requirements
- Knowledge of external customer requirements
- Knowledge of regulations
- Necessary professional training for FvP responsibility
- Sufficient experience for FvP responsibility accepted by authorities
- Ability to coach and develop others
- Investing in people
- Amplifying strengths to build talent
- Decision making with minimal direction
- Excellence focus
- Driving results through prioritization
- Driving results through continuous improvement
- Influencing stakeholders
- Shaping communication
- Negotiating to win
- Motivating teams
- Building relationships
- Inspiring followership
- Business Acumen
- Understanding QA connection to business objectives
- Embracing change
- Promoting change
- Driving change
- Excellent written communication skills
- Excellent oral communication skills
Aufgaben
- Provide leadership and oversight of Quality Compliance matters
- Ensure technical supervision of operations
- Guarantee safety, efficacy, and quality of medicines
- Handle pharmaceutical product activities
- Comply with Swiss law on Medicinal Products and AbbVie policies
- Manage storage and distribution activities
- Handle product complaints and quality events
- Conduct supplier controls and product quality reviews
- Manage risk and agency inspections
- Implement and maintain Quality Management System
- Ensure compliance with Good Distribution Practice
- Monitor controlled temperature and cold chain shipments
- Represent QA in regional and global teams
- Ensure medicinal products meet approved specifications
- Release commercial products for the Swiss market
- Decide on batch release and distribution
- Manage quality and compliance risks
- Approve SOPs and controlled documents
- Authorize return to saleable stock or destruction
- Approve Technical/Quality Agreements
- Audit external service providers
- Perform Product Quality Review
- Manage product recalls
- Handle product quality complaints
- Report quality issues to Swissmedic
- Manage quality issues with suppliers and manufacturers
- Stay updated with Swiss regulatory requirements
- Disseminate applicable regulations to stakeholders
- Act as contact person for Quality issues
- Plan and perform internal audits
- Report Site Quality Compliance Metrics
- Ensure GDP refresher training for employees
- Participate in GMP/GDP courses annually
- Assess and delegate responsibilities to Deputy FvP
Berufserfahrung
- 5 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- SAP
- TrackWise
- ComplianceWire
- OneVault
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AbbVie 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
AbbVie
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen setzt sich für die Entdeckung und Bereitstellung innovativer Medikamente und Lösungen ein, die ernsthafte Gesundheitsprobleme lösen.
Noch nicht perfekt?
- Viatris Pharma GmbH
QA Manager(m/w/x)
Vollzeitnur vor OrtSeniorZug - Merck & Co., Inc., Rahway, NJ, USA
Associate Director Quality Assurance(m/w/x)
Vollzeitnur vor OrtSeniorLuzern - Viatris Pharma GmbH
Manager Quality Assurance(m/w/x)
Vollzeitnur vor OrtManagementZug - Viatris Pharma GmbH
Head of Quality Assurance(m/w/x)
Vollzeitnur vor OrtSeniorZug, Steinhausen - Creoptix AG
Manager Operations/Plant Manager(m/w/x)
Vollzeitnur vor OrtSeniorWädenswil