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Associate Director, Quality Assurance

Date: Sep 23, 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 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 Associate Director of Quality Assurance is responsible for all activities and responsibilities that ensure that a product or service is effective, safe, and in compliance with all regulatory requirements. Develops and maintains a systematic process of determining whether any product or service meets specified requirements, with an emphasis on detecting problems and/or defects before getting to market.  

•    Review of all documentation associated with a batch in order to establish a disposition decision of release or rejection. This includes batch record (manufacturing and/or packaging records), test results, deviation review for closure, LIR review for closure, approved validation, COA, Change Controls, etc. Review of step by step performance and compliance to batch mfg/pkg record requirements and resolution of any errors/deviations identified.
•    Development of corrective and preventive actions in order to resolve an event with execution of action plans. Requires review, approval, and on time closure of the CAPA. Process of reviewing effectiveness or executing a protocol to determine the effectiveness of a corrective or preventive action.
•    Manage all processes for the QA team including creating and tracking complaint records, liaison with mfg sites, reviewing investigations, issuing closing letters, monitoring complaint analytics/trends and dpt performance metrics.
•    Investigation into an event including laboratory events with resolution including corrective and preventive actions along with effectiveness determination. Requires review, approval, and on time closure of the investigation. Some writing of deviations specific to the Quality Unit will be needed.
•    Quality oversight of maintenance and calibration activities including facilities and equipment and any critical systems such as purified water.
•    Quality interface with internal/external customers when dealing with activities such as issue resolution, complaints, product information, or for movement of materials, products, or process from site to site.
•    Observe, review, and audit operations activities in order to facilitate batch review and to assure compliance. 
•    Timely sample shipment, delivery, and/or receipt to assure compliance with regulatory requirements and shipping instructions, coordinate/approve route validation and investigation of temperature excursions as required for materials, components, drug substance/drug product.
•    Oversight/review/approval of R&D product development at the site and batch manufacture in GMP areas including resolution of deviations. Provide supporting information to Regulatory Affairs for Market Authorization (MA) application and maintenance.
•    Review of all documentation associated with a raw material batch or other components (i.e. packaging materials, labeling) in order to establish a disposition of release or rejection. Includes sampling and inspection records, test results, LIR review/closure, COA, etc.
•    Lead specific sections of inspection as an SME/Process owner. Assists in the preparation and review of regulatory agency correspondence to include responses to queries, responses to inspectional observations. Site planning and preparation activities to ensure Inspection Readiness at all times.
•    Normal supervisory activities for group's annual goals, performance/appraisals and development plans. Develops/Maintains department budget.
•    Site liaison w/ regional/global quality groups for implementation of best practice initiatives, market action decisions, and/or input on new and revised corporation standards/policies.

Qualifications

•    BS/BA in a Science or related field.    
•    5+ years in the Pharmaceutical Industry in Quality Compliance/Quality Assurance and/or Operations.
•    3+ years in a leadership role.
•    Knowledge of Complaint Evaluations, Batch Records and Investigations required.
•    Knowledge of Regulatory Procedure FDA 21 CFR Part 11, with a good understanding of GxP related processes.
•    Ability to adapt to a fast-paced and dynamic environment.
•    Ability to identify and direct procedural or process improvement to ensure state of compliance.
•    Advocates the value of diversity and fosters a culture of collaboration .
•    Communicates effectively at all levels in the organization.
•    Highly self-motivated, self-directed, and attentive to detail.
•    Ability to work both independently or as part of a team.
•    Leads change management initiatives and identifies areas where teams/departments could improve to be more effective in working through difficult transitions.
•    Leads continuous improvement programs using Lean Six Sigma and/or Operational Excellence principles to achieve site/department goals while maintaining compliance. 
•    Working knowledge of electronic batch records, SAP, and Trackwise 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

Manufacturing Quality Assurance

Reports To

In process of validation

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.


Nearest Major Market: Cincinnati