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Associate Director, Laboratory Quality Compliance

Date: Sep 22, 2022

Location: West Chester, US, 19380

Company: Teva Pharmaceuticals

Who are we?

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. 

Job Description

The Associate Director, Laboratory Quality Compliance is responsible for Quality Assurance oversight of all activities associated with GMP Laboratory activities supporting operational activities for the Biological Manufacturing Facility (BMF). 

Primary Responsibilities 

  • Provide QA support for GMP activities in laboratories with regards to all aspects of the GMP activities related to DS manufacture.
  • Provide support, oversight review and approval (as required ) for: analytical method validation (HPLC etc), Cell-based Potency Assay validation, Analytical Tech Transfer, quality oversight of GMP laboratory operations including walkthroughs and process evaluation.
  • Facilitate and provide expertise in OOS/OOT Lab Investigations.
  • Review CAPA action plans; facilitate plan completion and ensure appropriate effectiveness checks.
  • Ensure activities are performed/completed using current Good Manufacturing Practices.
  • Serve as Quality resource, representing QA on teams in support of assignments.
  • Provide feed-back/communication of any issues.
  • Review and approve SOPs, work instructions, and controlled forms.
  • Utilize Quality Systems to review and approve change controls, deviations, investigations, CAPAs and CAPA Effectiveness checks.
  • Participate/support regulatory agency filings, inspections, and internal audits, as needed. 


  • Bachelor's degree in life science discipline required.
  • Knowledge in Quality Compliance (cGMP/ ICH /FDA/ EMA/ USP / EP policies/guidelines) required.
  • Working knowledge of 21 CFR Part 11, SDLC, Annexes 11 / 15, GAMP 5 and FDA Guidance on analytical method validation and transfer expectations required.
  • Experience in cGMP Pharmaceutical or Biopharmaceutical manufacturing required.
  • Experience with Clinical Trials Phase I - III, and Process validation activities a plus.
  • Strong understanding of analytical and cell-based techniques is required.
  • Strong understanding of and practical experience with Empower software is preferred. 
  • Proficient with Microsoft Word and Excel.
  • Working knowledge of cGMP documentation practices required. Experience in review of Regulatory submission documentation a plus.
  • Experience with LIMS and TrackWise preferred.
  • Minimum 5 years of experience in laboratories working in the areas listed above required.
  • Minimum 3 years of Quality Assurance experience required.


Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations.




Sub Function

R&D Quality

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.


Inclusion & Diversity at Teva
Empowering our diverse employee base and creating an inclusive culture is both a business imperative and an opportunity to bring us closer to our patients, our partners and our communities. Teva employees respect and embrace a diverse range of experiences, capabilities and perspectives that connect us to new insights and opportunities, while building a more inclusive culture for all. We strive to enable a work environment where all employees can feel engaged and know they are making an important contribution to improving health and making people feel better.

Nearest Major Market: Philadelphia