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Senior Manager, EMSO Quality Systems & Compliance

Date: Aug 4, 2022

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.

 

This position is eligible for relocation assistance.

Job Description

The Sr Manager, EMSO Quality Systems and Compliance is accountable to ensure deliverance of revenue and free cash flow for products within the EMSO Americas division, including committed Customer Service Levels and On-Time In-Full (OTIF) targets, while ensuring process and system improvement deliverables. The Sr. Manager will support the delivery of systems, processes, and operations to manage drug, biologic, combination or device products produced by Teva’s Third Party external manufacturing and packaging partners, which meet established standards of quality including reliability, usability, and performance. Ensures ongoing compliance with quality and industry regulatory requirements for cGMPs, 21CFR 210/211, 21CFR 820 and 21CFR Part 4.


Key Responsibilities
•    Develop/Enhance, define, and implement systems and processes that deliver compliant, safe, and effective products. 
•    Lead projects for regulatory commitments (such as Nitrosamines), continuous improvements and efficiencies, and implements changes to deliver on compliance and savings. Lead remediation plans and activities. Prepare reports and presentations with KPIs and report to management on status.
•    Develop, define, and implement Quality KPIs that measure, analyze, and continuously improve the delivery of compliant, safe, and effective products. Prepare reports and presentations with KPIs and report to management at Quality Councils and Management Review.
•    Managing actions from Quality Council and Management Review.
•    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.
•    QMS implementation.

 

Qualifications

•    Bachelor’s degree in Science or Engineering with a minimum of (10) years’ experience in a Pharmaceutical FDA regulated industry in Quality Assurance or related field required.
•    Must have working knowledge of cGMPs, CFR (210/211/ 820/4), ICH and applicable international regulations/guidelines required.
•    Experience with Quality Systems such as electronic deviation and documentation management systems, SAP, and serialization required.
•    Strong computer skills including TrackWise, Oracle and SAP is desired.

 

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.

Function

Quality

Sub Function

Quality Compliance

Reports To

Associate Director, TPO Quality Systems & Compliance

Already Working @TEVA?

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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: New York City
Nearest Secondary Market: Newark