Associate Director Quality and Compliance (SME) - TAPI Date: Sep 18, 2024 Location: Rho, Italy, 0000 Company: Teva Pharmaceuticals Job Id: 58364 Who we are 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.
Our employees are at the core of our success.
TAPI employs more than 4,000 professionals at 14 sites worldwide.
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 RD centers, securing compliance of activities, quality risk management, escalation of risks, and continuous improvement.
You will 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 day 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.
Prepare sites for successful Health Authority inspections.
Support TAPI sites in the implementation of a Quality Risk Management system.
Monitor and communicate regulatory actions and compliance risks.
Coordinate the implementation of Global Projects improving patient supply and quality compliance.
Lead and conduct best practice and knowledge sharing routine forum meetings.
Conducting data Integrity gap assessments at sites.
Participate in Human error reduction program.
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 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.
APIs Manufacturing / SME experience required.
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.
Fluent in English – a must.
Contact person Vincent van Straten - Team Lead Recruitment 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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