Senior Quality Compliance Manager

4 settimane fa

Rho, Lombardia, Italia Teva Pharmaceuticals A tempo pieno

About the Role

We are seeking a highly skilled Senior Quality Compliance Manager to join our team at Teva Pharmaceuticals. As a key member of our Quality Assurance department, you will be responsible for ensuring that our manufacturing sites and R&D centers maintain a robust Quality Compliance System, guaranteeing compliance with regulatory requirements and industry standards.

Key Responsibilities

  • Develop and implement Quality Compliance Systems to ensure compliance with regulatory requirements and industry standards.
  • Collaborate with site compliance teams to implement, maintain, and improve site inspection readiness programs.
  • Support complex investigations at sites to ensure comprehensive, scientific, and well-written investigations and robust root cause analysis tools with appropriate CAPA.
  • Prepare sites for successful Health Authority inspections, including pre-inspection, during-inspection, and post-inspection support.
  • Support the implementation of Quality Risk Management systems to assess, control, communicate, and review risks that may negatively affect product quality.
  • Monitor and communicate regulatory actions and other compliance risks resulting in Critical Vendor Issues.
  • Coordinate the implementation of Global Projects improving patient supply and quality compliance of TAPI sites, processes, and systems.
  • Lead and conduct best practice and knowledge sharing routine forum meetings to share learnings from inspections and CAPAs or continuous improvements.
  • Conduct data Integrity gap assessments at sites and propose corrective actions.
  • Participate in Human error reduction programs, conducting assessments and proposing CAPAs to reduce LIRs/OOS/Batch failures, deviations, etc.
  • Ensure CAPA implementations and effectiveness checks are executed timely at sites and monitor CAPA programs.
  • Knowledge in CFR Part 11, Annex 11, and PIC/S guidance, CCS strategy implementation at sites.
  • Knowledge in current regulatory guidance of USFDA, EMEA, PIC/S, MHRA, PMDA, ANVISA, COFEPRIS.

Requirements

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

Contact Information

Vincent van Straten - Team Lead Recruitment

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