Quality Compliance Director

2 settimane fa

Rho, Lombardia, Italia Teva Pharmaceuticals A tempo pieno

Job Overview

The ideal candidate for this position will be responsible for ensuring that TAPI manufacturing sites and R&D centers maintain a Quality Compliance System, guaranteeing compliance of activities, quality risk management, escalation of risks, and continuous improvement.

Key Responsibilities


  2. Lead the implementation, maintenance, change process, and continuous improvement plans for the site inspection readiness program in collaboration with site compliance teams.
  3. Support complex investigations at sites, ensuring comprehensive, scientific, well-written investigations and robust root cause analysis tools with appropriate CAPA are in place.
  4. Prepare sites by providing input, guidance, and support for successful Health Authority inspections, including pre-inspection, during the inspection, preparation of responses, and post-inspection support for follow-up commitments.
  5. Support TAPI sites in the implementation of a Quality Risk Management system, assessing, controlling, communicating, and reviewing risks that may negatively affect product quality.
  6. Monitor and communicate regulatory actions and other compliance risks resulting in Critical Vendor Issues.
  7. Coordinate the implementation of Global Projects improving patient supply and quality compliance of TAPI sites, processes, and systems, such as deviation reduction initiatives, reduction of human error investigations, data integrity implementation, and inspection readiness.
  8. Lead and conduct best practice and knowledge sharing routine forum meetings to share across sites the learnings from inspections and CAPAs or continuous improvements resulting from inspections.
  9. Conduct data integrity gap assessments at sites and propose corrective actions.
  10. Participate in Human error reduction programs, conducting assessments and proposing CAPAs to reduce LIRs/OOS/Batch failures, deviations, etc.
  11. Ensure CAPA implementations and effectiveness checks are executed timely at sites and monitor the CAPA programs.
  12. Knowledge in CFR Part 11, Annex 11, and PIC/S guidance, CCS strategy implementation at sites.
  13. Knowledge in current regulatory guidance of USFDA, EMEA, PIC/S, MHRA, PMDA, ANVISA, and COFEPRIS.

Requirements


  2. Bachelor's Degree – chemistry, microbiology, pharmacy, engineering, or related science-based degree.
  3. Master's Degree preferred – in science, business, healthcare, or an equivalent combination of education and experience related to Quality Assurance/Quality Control – an advantage at large and complex sites.
  4. Professional certifications a must when required legally.
  5. APIs Manufacturing/SME experience required. Sterile API expertise a plus.
  6. Experience: 15+ years of experience as a functional leader with technical, team management, and operational responsibility. Continuous professional development.
  7. Advanced practical knowledge of pharmaceuticals manufacturing and control, facility design, utilities, maintenance, and calibration.
  8. Advanced knowledge of local current and upcoming legislation and current Quality best practices. International experience an advantage.
  9. Advanced knowledge of cGMP requirements for products and processes.
  10. Advanced understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Documentation, etc.
  11. Fundamental knowledge of MRP Systems and GMP impacting computer systems, like TrackWise TAPI, Priority, StarLIMS, and software platforms typically used by TAPI.
  12. Ability to understand and execute against TAPI Quality Management System.
  13. Advanced knowledge of quality systems.
  14. Advanced experience in working with matrix environments.
  15. Advanced knowledge in Auditing and Problem Solving.
  16. Advanced knowledge in Quality Oversight.
  17. Expert communication skills – written and verbal – and advanced team work skills.
  18. Must be able to travel based on business need; up to 50% when required (domestic and international).
  19. Fluent in English – a must.

Contact Person

Vincent van Straten - Team Lead Recruitment

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