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TPO (Third Party Operations) Quality Manager

Date: Oct 11, 2021

Location: Parsippany, New Jersey, US, 07054

Company: Teva Pharmaceuticals

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

As our TPO Quality Manager, you will be accountable for delivering systems, processes, and operations to manage drug, biologic, combination or device products produced by Teva’s Third Party external manufacturing and packaging partners (meeting established standards of quality including reliability, usability, and performance). You will ensure ongoing compliance with quality and industry regulatory requirements for cGMPs, 21CFR 210/211, 21CFR 820 and 21CFR Part 4.

 

The TPO Quality manager will:

  • Manage the Quality Systems and Compliance, such as Training, Documentation, and author Notification to Management (NTM)/ Field Alert Report (FAR)s for Supply Relationship Team (SRT). Reply to FDA inquiries and requests.
  • Manage Supplier Qualification though Due Diligence/Audit support, QTAs, and authorization of Master Documents.
  • Develop/Enhance, define, and implement systems and processes that deliver compliant, safe, and effective products.
  • Identify and lead projects for continuous improvements and efficiencies, and implement changes to deliver on compliance and savings.
  • Define Quality KPIs that measure, analyze, and continuously improve the delivery of compliant, safe, and effective products at the SRT level.
  • Host and manage Quality Councils and Management Review for SRT, including tracking and managing actions.
  • Manage the Product Quality Customer Complaint investigation process for the SRT, including approval of complaints.
  • Manage Analytical support to SRT including Method Transfers and OOS support. Ensure the implementation of approved release and shelf life specifications and all corresponding methods by (Contract Manufacturing Organization) CMO and if needed Teva Laboratories. Ensure the compliance of methods to GMP standards and the dossier.
  • Manage the Change Management process for SRT. Ensure changes concerning registration/submission are submitted to the authority in collaboration with TPO, Change Control Management, and RA/Regulatory Affairs.
  • Manage the Annual Product Quality Reviews (APQR) for the SRT. Review of the APQRs for completeness and plausibility in case of discrepancies detected by the central APQR team. Initiate follow up activities / CAPA.
  • Evaluate Standards and Regulations against local SOPs to identify and eliminate gaps in policies. Develop, recommend and monitor corrective and preventive actions (CAPA) and CAPA effectiveness reviews.

Qualifications

  • Bachelor’s degree in Science or Engineering required.
  • 10+ years’ Quality Assurance experience in an FDA regulated industry (Pharma or similar).
  • Must have working knowledge of cGMPs, CFR (210/211/ 820/4), ICH and applicable international regulations/guidelines.
  • Experience with Quality Systems such as electronic deviation and documentation management systems, SAP, and serialization as well as hosting Quality Councils and Management Review.
  • Analytical Lab experience and experience with external pharmaceutical manufacturing, packaging, testing and devices is desired.
  • Experience with liquid, creams and ointments (LCO), solid dosage, sterile products desired.
  • Related systems skills including TrackWise, Oracle and SAP desired.

Function

Quality

Sub Function

Supplier Quality

Reports To

Assoc Dir Global Quality Function, Quality Third Party Ops (USA)

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.

Teva’s 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.

We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.


Nearest Major Market: New York City
Nearest Secondary Market: Newark