Associate Director Quality And Compliance

1 settimana fa

Lombardia, Italia Buscojobs A tempo pieno

The opportunity

The main purpose of your job will be to ensure that a Quality Compliance System is in place at TAPI manufacturing sites and R&D centers, securing compliance of activities, quality risk management, escalation of risks, and continuous improvement. Your role will include providing governance through strong collaboration with manufacturing site operations to foster excellence in inspection management and inspection readiness at TAPI sites. You will also interact across the matrixed organization specifically with TAPI‘s Global Quality Compliance, Manufacturing Science & Technology, Research & Development, Supply Chain Operations, Regulatory Affairs and other network manufacturing and supply sites. You will also ensure that each site receives the right level of support to maintain and enhance GMP compliance, to solve quality-related service issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance to TAPI standards. Moreover, you will foster and develop onsite Quality culture across all TAPI sites.

If you are interested to apply, then we would love to see your application in English.

How you’ll spend your day

  • In collaboration with site compliance teams, support the implementation, maintenance, change process, and continuous improvement plans for the site inspection readiness program.
  • Support complex investigations at the sites to ensure comprehensive, scientific, well-written investigations and that robust root cause analysis tools with appropriate CAPA are in place.
  • Prepare sites by providing input, guidance, and support for successful Health Authority inspections. This may include pre-inspection, during the inspection as part of inspection management, preparation of responses, and post inspection support for follow up commitments.
  • Support TAPI sites in the implementation of a Quality Risk Management system, to assess, control, communicate, and review risks that may negatively affect the quality of the products.
  • 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 e.g. deviation reduction initiatives, reduction of human error investigations, data integrity implementation and inspection readiness.
  • Lead and conduct best practice and knowledge sharing routine forum meetings to share across sites the learnings from inspections and the CAPAs or continuous improvements that result from the inspections.
  • Conduct data Integrity gap assessments at sites and proposing corrective actions.
  • Participate in Human error reduction program, 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 the 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.

Your experience and qualifications

  • 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 - advantage at large and complex sites.
  • 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 person

Vincent van Straten - Team Lead Recruitment

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