1+ months

Senior Director, Regional Compliance Lead--Americas

Parsippany, NJ 07054
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!

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day.  We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

Job Description

Position Summary

The overall purpose of this role is to drive compliance actions and improvements from Global Compliance to the sites ensuring a culture of continuous improvement and a high level of compliance resulting in successful regulatory inspections. You will serve as the liaison between the Site Quality Heads (and sites) and Global Compliance.  

Key Responsibilities

  • Lead/mentor a team of compliance specialists setting strategic goals and objectives for the group in alignment with Global Compliance and site based Quality operations.
  • Work in alignment with regional Compliance leaders (matrix reporting to this role) for our Canadian and Latin American markets to drive harmonization of standards across sub-regions for the Americas.
  • Implement a site support strategy whereby the team is on site (target 50% of the time) providing support, guidance, and expertise 
  • Design and lead a robust interactive regional Quality Council that is effective in identifying site based compliance risks, opportunities to improve compliance performance, regional trends, and the resultant actions to improve performance and prevent reoccurrence.
  • Effectively manage knowledge sharing across the region to ensure learnings from regulatory inspections, internal audits, or other sources are shared to ensure harmonization of CAPA plans and prevention across all sites.
  • Provide significant contribution and recommendations for product recall decisions.
  • Identify, design, and implement identified improvements to Quality Systems across sites that balance both the compliance requirements and business needs.
  • Manage and report out on key Quality indicators and KPIs for the region
  • Design the expectations required (of the group) for site based visits aligned with Goals and Objectives with specific focus on site inspection readiness, SME capabilities, risk identification, and harmonization across sites.
  • Provide timely support to sites upon request to mitigate urgent compliance risks and / or provide the necessary on-site presence to facilitate tasks or remediation as required
Qualifications
  • Bachelors degree in a related technical or scientific discipline
  • Minimum 10 years of experience in Quality and Operations, including a minimum of 7 years in a compliance based leadership role
  • Significant, direct interaction with health authorities
  • Direct "hands-on" experience leading complex, cross company compliance efforts, interacting with or knowledge of multiple Health Authorities
  • Experience balancing the requirements of the business while ensuring sustained compliance through defendable compliant flexible solutions
  • Deep/thorough knowledge of global regulations (impacting Teva's business) with the ability to interpret and apply those requirements
  • Multifunctional Technical knowledge (Compliance, Quality, Operations) sufficient to make decisions on product market actions.
  • Thorough knowledge and understanding in Quality and Operational processes along the entire business value chain
  • Deep understanding and strong connections to the Health Authorities across the supply markets, (not only FDA).
Function
Quality
Sub Function
Quality Assurance Methods
Reports To

Senior Vice President, Quality Operations--Americas with matrix reporting relationship to Global Head of Compliance

Tevas 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.

Categories

Posted: 2019-06-17 Expires: 2019-09-15

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Senior Director, Regional Compliance Lead--Americas

Teva Pharmaceuticals
Parsippany, NJ 07054

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