Teva Pharmaceuticals
Head of Quality Manufacturing, EU, India & LATAM Solids & LCO cluster(m/w/x)
Vollzeit
Senior
Keine Angabe
Ulm
TE
Teva Pharmaceuticals4 Monate
Senior Director, Site Quality Head(m/w/x)
Vollzeit
Senior
Keine Angabe
Ulm
Nejo KI-Zusammenfassung
In this role, you will lead quality oversight for manufacturing and laboratory operations, ensuring compliance with regulations and fostering a culture of quality. Your daily responsibilities will include managing quality systems, overseeing investigations, and collaborating with site leadership to meet project objectives.
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Anforderungen
- •Bachelor’s degree in chemistry, biology, or pharmacy
- •Master or equivalent degree in chemistry, biology, or pharmacy
- •Minimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience
- •Deep knowledge of cGMP requirements of local and major international authorities
- •High level of understanding of manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines, and CMC content
- •Deep knowledge of chemical/pharmaceutical production operations and relevant technologies
- •Strong understanding and experience in Data Integrity and Compliance
- •Experience preparing and/or leading regulatory authority GMP
- •Deep knowledge of Quality Systems
- •Proven successful track record of leading organizational change to improve efficiency
- •Experience leading, inspiring, and coaching large teams
- •Experience developing and implementing efficient business processes
- •Adequate knowledge of Quality best practices
- •Adequate practical knowledge of pharmaceuticals manufacturing and/or control
- •Adequate practical knowledge of analytical techniques and microbiological principles
- •Practical knowledge of pharmaceutical cross-functional operations
- •Practical knowledge on lean manufacturing and OPEX tools
- •Good knowledge of environmental, health, and safety requirements for laboratories
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
10 Jahre
Deine Aufgaben
- •Oversee quality for manufacturing, packaging, and laboratory operations
- •Establish and execute quality procedures
- •Manage licensing and quality activities on the floor
- •Conduct audits and release products
- •Handle laboratory investigations, deviations, and complaints
- •Create and implement CAPA plans
- •Analyze trends and metrics for compliance
- •Verify maintenance of equipment, facilities, and utility systems
- •Lead development and standardization of quality systems
- •Monitor effectiveness of compliance programs and initiatives
- •Influence proactive process improvement programs
- •Lead the quality organization, including Quality Control and Assurance
- •Ensure continuous improvement of the Quality Management System
- •Guarantee compliance with cGMP requirements and specifications
- •Assess and mitigate quality risks before market release
- •Design and implement the site quality program
- •Manage delivery of quality data to stakeholders
- •Oversee laboratory activities and material testing
- •Promote a culture of quality across the site
- •Maintain partnerships with site leadership and other departments
- •Provide quality leadership during inspections
- •Ensure quality KPIs meet targets and monitor CAPA effectiveness
- •Plan and manage the annual Quality Operations budget
Sprachen
Englisch – verhandlungssicher
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