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Manager Quality Assurance

Date: May 14, 2022

Location: Cincinnati, Ohio, US, 45213

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 onthe first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee StockPurchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

Job Description

This position is responsible for the facilitation and management of operational Quality Assurance functions which includes batch record issuance, batch record review, product disposition, shop floor support, raw material release, calibration and maintenance record review and approval, in-process inspections, and other operational quality requirements. Additional responsibilities include effectively executing compliance audits of product/component documentation, issuance of appropriate status to components and product, participation in investigations, trending of quality issues as appropriate, and supporting data collection and department reporting activities to support both the GMP and regulatory requirements of the product.

 

• Responsible for the daily management and development of direct and indirect reports supporting quality operations and shop floor resolution of issues, including participation in deviation reports
• Responsible for coordinating and participating in the development, implementation and maintenance of quality assurance systems to ensure compliance with FDA regulations.
• Responsible for managing all information necessary for the proper decisions on approval or rejection of all components, drug product containers, in-process materials, packaging materials, labeling and drug products manufactured.
• Responsible for the review and approval of standard operating procedures, master production records and EAM system management.
• Responsible for management of retain inventory throughout the specified retention period for all commercial products.
• Responsible for developing, implementing and maintaining training plan and curriculum to assure compliance with applicable regulatory requirements.
• Responsible for compliance to in-house specifications/standards and Good Manufacturing Practices including maintaining related documentation (eg acceptance specifications, test methods, batch records) and ensuring the company stays current of new developments related to Good Manufacturing Practices and the quality functions.
• Responsible for the review of production processes and records to assure quality; analyze trends.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures(SOP’s) and Batch Record instructions.
 

Qualifications

• Requires Bachelor’s Degree, preferably in a scientific or engineering discipline with a minimum of 5 years relevant progressive experience in the pharmaceutical or related industry. Any equivalent combination of education/experience will be considered.
• Supervisory or management experience (highly preferred).
• Experience with and knowledge of US Pharmaceutical regulations and practices (highly preferred).
• Strong audit and documentation assessment experience (highly preferred).
• Experience with internal auditing and regulatory inspections (highly preferred).
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS and TrackWise.

Function

Quality

Sub Function

Manufacturing Quality Assurance

Reports To

Sr Dir, Site Quality Head, Cincinnati, Quality Management IV (US 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.


Nearest Major Market: Cincinnati