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 support 80% of top 50 global pharmaceutical companies. Our reliable history in the generic API industry dates back over 80 years, and we are considered one of the most trusted API suppliers, enabling TAPI to lead the industry based on our experience, expertise, technologies, and exceptional customer service.
Our employees are at the core of our success. Headquartered in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market.
Location of the position
This position is available in Rho (IT), Zagreb (CRO), Debrecen (HUN), or Opava (CZ).
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 ensure that each site receives the right level of support to maintain and enhance GMP compliance, solve quality-related service issues, and identify areas of improvement for quality operational performance in line with business needs and TAPI standards. Moreover, you will foster and develop onsite Quality culture across all TAPI sites.
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, including pre-inspection, during the inspection, and post-inspection support for follow-up commitments. Support TAPI sites in implementing a Quality Risk Management system 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 resulting 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 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. Professional certifications a must when required legally. Experience: 15+ years in a functional leadership role with technical, team management, and operational responsibility. Advanced practical knowledge of 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 processes. Advanced understanding of various quality functions like QC, QA, Quality Systems, Compliance, Documentation, etc. 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 and auditing. Expert communication skills – written and verbal, and advanced teamwork skills. Must be able to travel based on business needs; up to 50% when required (domestic and international). Fluent in English – a must. Contact person
Reports To
Head of Quality Compliance TAPI
Teva's Equal Employment Opportunity Commitment
Teva 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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