Associate Director Quality and Compliance (SME) - TAPI Date: Sep 18, 2024
Location: Rho, Italy, 0000
Job Id: 58364
TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products, we are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers. Our employees are at the core of our success. Our headquarters is in Israel, and TAPI employs more than 4,000 professionals at 14 sites worldwide.
Location of the positionThis position is available in Rho (IT), Zagreb (CRO), Debrecen (HUN) or Opava (CZ)
The opportunityThe 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.
How you'll spend your dayIn 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.Support TAPI sites in the implementation of a Quality Risk Management system.Monitor and communicate regulatory actions and other compliance risks.Coordinate the implementation of Global Projects improving patient supply and quality compliance of TAPI sites.Lead and conduct best practice and knowledge sharing routine forum meetings.Conducting data Integrity gap assessments at sites and proposing corrective actions.Participate in Human error reduction program, conducting assessments and proposing CAPAs.Ensure CAPA implementations and effectiveness checks are executed timely at sites.Knowledge in CFR Part 11, Annex 11 and PIC/S guidance.Knowledge in current regulatory guidance of USFDA, EMEA, PIC/S, MHRA, PMDA, ANVISA, COFEPRIS.Your experience and qualificationsBachelor'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.Experience: 15+ years of experience as a functional leader with technical, team management, and operational responsibility.Advanced practical knowledge pharmaceuticals manufacturing and control.Advanced knowledge of local current and upcoming legislation and current Quality best practices.Advanced knowledge of cGMP requirements for products and process.Advanced understanding of quality functions like QC, QA, Quality Systems, Compliance, Documentation.Fundamental knowledge of MRP Systems and GMP impacting computer systems.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.Expert communication skills – written and verbal.Must be able to travel based on business need; up to 50% when required (domestic and international).Fluent in English – a must.Contact personReports ToHead of Quality Compliance TAPI
Teva's Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
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