Associate Director Quality and Compliance Specialist
3 giorni fa
The Opportunity
We are seeking a highly experienced Associate Director Quality and Compliance to join our team at Teva Pharmaceuticals. As a key member of our Quality and Compliance department, you will be responsible for ensuring that our Quality Compliance System is in place at our manufacturing sites and R&D centers, securing compliance of activities, quality risk management, escalation of risks, and continuous improvement.
Your Key Responsibilities
- Collaborate with site compliance teams to implement, maintain, and improve the site inspection readiness program.
- Support complex investigations at sites to ensure comprehensive, scientific, and well-written investigations and robust root cause analysis tools with appropriate CAPA are in place.
- Prepare sites for successful Health Authority inspections, including pre-inspection, during the inspection, and post-inspection support for follow-up commitments.
- Support the implementation of a Quality Risk Management system to assess, control, communicate, and review risks that may negatively affect the quality of our 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 our 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 the CAPA programs.
Your Qualifications
- Bachelor's Degree in chemistry, microbiology, pharmacy, engineering, or a 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.
- 15+ years of experience as a functional leader 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 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.
- Ability to understand and execute against Teva Pharmaceuticals' Quality Management System.
- Advanced knowledge of quality systems.
- Advanced experience in working with matrix environments.
- Advanced knowledge in Auditing and Problem Solving.
- Advanced knowledge in Quality Oversight.
- Expert communication skills – written and verbal and advanced team work skills.
- Fluent in English – a must.
Contact Person
Vincent van Straten - Team Lead Recruitment
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