Senior Manager Quality ​/ Responsible Person (TPIG) (m​/f​/d) 100

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

• Responsible for quality oversight and regulatory compliance of processes and products within scope of activities for Teva Pharmaceuticals International GmbH (TPIG)
• Responsible for quality approval and management of 3rd party suppliers/manufacturers
• Roll out of Teva Quality Management System at business unit level
• Ensure operational implementation of Quality Management System in compliance with GMP/GDP and Teva Corporate and Regional Standards
• Report to Global Quality and local Management any critical quality incident with the corresponding corrective action plan
• Primary company contact with local Health Authorities in relation to a.o. GMP/GDP inspections, quality incidents and recalls

Rolling out of Teva Quality Management System

• Create, maintain up-to-date and distribute Standard Operating Procedures and Working Instructions as per Teva standard and in compliance with national regulations
• Ensure GMP/GDP compliance at the business unit and promote the quality culture
• Lead GMP and GDP training at a local level
• Initiate continuous improvement of processes
• Attend to periodic quality councils
• Provide quality metrics per defined frequency
• Keep appropriate records of any delegated duties

• Product trading
  - Ensure the distribution traceability of finished products and returns of products traded by the company
• Distribution
  - Ensure the GDP compliance of the distribution centers
• KPIs
  - Perform Management Review as per defined frequency
• In case of recall ensure the local coordination between PhV, medical affairs, regulatory affairs, supply chain, etc. and with EU Qualified person concerned. Escalate any critical information to Global Quality and regional Commercial Quality and issue the final recall report, as applicable.
• Change control, deviations and CAPAs
  - Administer, maintain and develop systems for change control, and deviation and CAPA handling
• Suppliers/manufacturers and 3rd party service providers
  - Maintain, monitor and approve a list of approved suppliers. Ensure that Quality Agreements are set up and kept up to date with all suppliers/ manufacturers and 3rd party service providers as required
• Supplier and customer authorization
  - Ensure that suppliers and customers are qualified. Maintain, monitor and approve a list of authorized suppliers and customers. Ensure that respective licenses and / or marketing authorizations are maintained
• Release for sale batches (Finished Goods, APIs) which are manufactured and released by third party suppliers
• Archiving
  - Ensure that relevant quality related documentation is archived as required
• Authority inspections and audits
  - Host and lead GMP/GDP related competent authority inspections. Perform or coordinate internal audits of the compliance of the Quality System
• Ensuring internal audits are performed at appropriate regular intervals following a prearranged program and necessary corrective actions are put in place
• Perform or coordinate external audits, with respect to quality related matters, of local warehouses/distributors and other…