1+ months

Associate Director Compliance Quality Solids Manufacturing & Supply Operations (SMSO)

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 partner with Tevas manufacturing sites to support complex investigations, regulatory inspections, and implementation of processes improvements and standardization through effective collaboration with subject matter experts.
You will provide governance of operations assuring quality systems are implemented and effective across operating sites. Governance is accomplished through risk based system assessment of the operations, inspection management and readiness at Teva sites as well as compliance upgrade activities and effectiveness checks of regulatory inspection commitments. You will support the Americas Regional (Canada, US, Latin America) sites to ensure compliance processes are efficiently in use and effective. 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   
Partner 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.
Manage 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.
Prepare and provide on-site support to Teva sites for regulatory inspections and third party audits as needed. Provide hosting and back room support.
Provide input and assist sites in completing inspection responses and the development of robust corrective actions to ensure consistency and appropriateness of commitments.  Review of regulatory inspection responses to ensure thorough response and consistency throughout the region.
Facilitates transparency and communication of lessons learned and best practice sharing across the network
Develops tools for implementation if an effective self-inspection program with training across sites
Develops and performs effectiveness checks of self-inspection programs at sites
Perform compliance investigations as needed, provide support and review complex investigation reports of non-compliances in GxP areas.
Conduct and support pre-approval / pre-submission project reviews, mock inspections and inspection readiness assessments.
Facilitate the regional responses for gNTMs. Publishes gNTMs to sites, consolidates responses, and report summarized response back to global coordinator.           

Qualifications

 

  • BS in Pharmacy, Engineering, Biology, Chemistry, Biochemistry, Microbiology, or related science discipline or equivalent combination of education and experience required             
  • Masters Degree in a Science discipline or Healthcare preferred
  • Minimum 15 years related pharmaceutical industry Quality Assurance Compliance experience, including pharmaceutical manufacturing site experience required
  • Expertise in a range of compliance topics, understanding and working knowledge of cGxPs and FDA Regulations required
  • Strong verbal and  written communication are required
  • Strong experience in Compliance and Health Authority interaction is  necessary
  • Working knowledge of audit and inspection management, response writing and CAPA management programs strongly preferred
  • Strong organization skills and project management experience are required
  • Strong leadership, facilitation, and organizational skills as well as the ability to work equally well as part of a team or independently is necessary
  • Must be able to travel up to 50% (domestic and international)
Function
Quality
Sub Function
Quality Compliance
Reports To

Senior Director, Americas Regional Compliance

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Categories

Posted: 2020-03-01 Expires: 2020-08-09

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 Compliance Quality Solids Manufacturing & Supply Operations (SMSO)

Teva Pharmaceuticals
Parsippany, NJ 07054

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