1+ months

Senior Manager, Quality Assurance

West Chester, PA 19380
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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


This position is located in West Chester, PA.

Job Description

 

Responsibilities include, but are not limited to:

 

Provide Quality Assurance leadership to support manufacturing activities at the Biologics R&D facility in West Chester, PA.


    Supervise QA specialists providing review and approval of master and executed batch records (buffers, solutions, media, cell banks, drug substance and drug product), this includes any manufacturing activities performed for R&D by third parties (either Teva sites and/or contract manufacturing organizations)
    Supervise QA specialists responsible for QA oversight of facilities, including equipment, utilities and environmental monitoring, including review and approval of validation plans, protocols and reports
    Provide QA leadership for the supplier management program and oversight of disposition activities for raw materials, components and consumables
    Support commercial product readiness activities
    Provide QA room/area clearance in support of manufacturing activities.  Support the QA On-the-Floor (QAOTF) program.
    Ensure site alignment with corporate policies and standards
    Participate in manufacturing-related technology transfer activities for products coming into the facility, as well as those being transferred to future phase 3/commercial sites
    Provide QA input and support for process validation activities
    Participate in internal audits and assist in management of regulatory and third-party audits of the Biologics site at West Chester


This role manages a team of QA specialists (5+) responsible for all activities related to manufacturing of biological drug substances and drug products at the West Chester, PA facility.  The Sr. Manager is responsible for providing performance reviews, merit increase, bonus and promotion recommendations for staff, recruitment and discipline of staff.

Qualifications


    BS degree required in life science, with a minimum of 10 years of experience in Biotechnology and Quality Assurance.
    Experience with QA oversight of manufacturing systems automation and computer system validation
 

Function
Quality
Sub Function
R&D Quality
Reports To

Quality Assurance Director 

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.

Posted: 2020-07-25 Expires: 2020-10-09

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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Senior Manager, Quality Assurance

Teva Pharmaceuticals
West Chester, PA 19380

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