Sr.Dir, teva api Quality Compliance & Support

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

1. Leading the team of TAPI  Quality compliance & support
2. Ensure that each site within TAPI 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 TEVA standards.
3. Foster and develop onsite Quality culture.

Key Responsibilities

• Lead the teva api Quality compliance & support team of highly professional specialist
• Member of the teva api Quality Leadership Team
• Ensure the corporate Quality Management System (QMS) is implemented and the local Quality Management Systems is up to date.
• Responsible for the management of the teva api Quality Council  
• Ensure the timely availability of data to the reporting portals and provision of teva api reports,
• Coordinates within the Compliance & Support Team the following tasks:
  • Coordinator Role of the Notifications to Management process within the teva api and the global Notifications to Management process, both in accordance to global standard including QAM and MAC meetings
  • Support of execution and coordination of recalls
  • Primary contact role for the distribution and implementation of corporate standards within teva api
  • SME assignment
  • Performance management and reporting

key responsibilities

• Coordinates the capacity of the compliance specialist in partnering with the sites to remediate any gaps identified in compliance, towards the QMS or in quality related service Site compliance reviews
• Investigation and remediation of non-compliances to corporate QMS
• Oversight to the evaluation of effectiveness of the corrective and preventive actions.
• Quality risk assessments
• Inspection readiness
• Data integrity governance
• Ensures continuous improvement of compliance and performance Establish and monitor governance on data integrity requirements.
• Establish and manage the teva api Change Control Forum

Qualifications

• Degree in Chemistry, Biology, Microbiology, Pharmacy or similar
• Demonstrated knowledge in cGXP regulations.
• 15+ years’ experience in GMP environment, continuous professional development,  cGXP regulations
• 10+ years’ experience in managerial tasks, to lead a quality department or organization
• Very good understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Microbiology, Documentation et
• Sound knowledge of regulatory standards and guidance in Pharmaceutical Industry and expectation of global regulatory bodies, specifically FDA, teva api, PMDA and Anvisa requirements
• Knowledge of Quality Systems, product types and manufacturing operations
• Ability to understand and execute against Teva Quality Management System
• Fluent in English
• travel regularly

Function

Sub Function

Reports To

VP, Quality R&D, Quality Compliance Mgmt IL

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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.