1+ months

Associate Director, Americas Regional Compliance Support

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  

You will support the Americas Regional (Canada, US, Latin America) sites to ensure compliance processes are effectively and efficiently managed. You will interact with both global and manufacturing sites. You will be responsible for monitoring, tracking, trending and reporting on the processes listed. You will facilitate critical incident management and assist site Quality Heads in various activities and processes.

 

Key Responsibilities     

  • Responsible for the effective, efficient, and compliant execution of the Critical event lifecycle elements associated with Notification to Management (NTM), Field Alert Reporting (FAR), Quality Alignment Meetings (QAM), and Market Action Committee (MAC).
  • Partners with manufacturing sites to ensure timely internal communication for all elements of a critical event, support investigational process for critical events, and facilitate the incident to resolution.
  • Manages activities to ensure Inspection Readiness at Teva sites.  This includes but is not limited to current and compliant SOPs, comprehensive and timely training, robust self-inspection process, compliant Quality Systems, and professional execution. 
  • Provides on-site support to Teva sites for regulatory inspections and third party audits as needed. Provide hosting and back room support.
  • Assists sites in completing inspection responses. Review of regulatory inspection responses to ensure thorough response and consistency throughout the region.
  • Prepares gap analysis against observations to prevent repeat observations at other Teva sites.
  • Facilitates the regional responses for Global Notifications to Management. Publishes gNTMs to sites, consolidates responses, and report summarized response back to global coordinator.             

 

 

Qualifications
  • BS in Biology, Chemistry, Biochemistry, Microbiology, or related science or equivalent combination of education and experience required             
  • Masters Degree in Science, Business, Healthcare or an equivalent combination of education and experience related to Quality Assurance/Quality Control preferred
  • Minimum 10 years related pharmaceutical industry Quality Assurance/compliance experience
  • Experience working in a pharmaceutical manufacturing plant within the last 5 years is preferred
  • A solid understanding and working knowledge of GMPs, FDA Regulations and Standard Operating Procedures are a must
  • Must be able to travel up to 30% (domestic and international)
Function
Quality
Sub Function
Quality Compliance
Reports To

Senior Director, Americas Regional Compliance Support

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: 2019-12-05 Expires: 2020-02-14

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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Associate Director, Americas Regional Compliance Support

Teva Pharmaceuticals
Parsippany, NJ 07054

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