19 days old

Associate Director, Quality

Cincinnati, OH 45202

Company Info

 

If youre like people at Teva, you dare to be different. Were making well-being a way of life for our customers and our colleagues. Join us in helping to make healthcare more accessible to more patients, while supporting one of the most innovative teams in the industry. 
Tevas Cinicinnati, Ohio production sites are one of our solid manufacturing and supply chain operations. 
We are strengthening and adding to our critical teams with great talent and capabilities. Teva, a global organization, with a brand of evolving success. Be part of it! 

 

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 

 

Teva is a global pharmaceutical leader and the worlds 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 worlds largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we have 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! 

Job Description

 

Teva is searching for an Associate Director, Quality Compliance to join our team in Cincinnati, OH!

The Associate Director of Quality Compliance is responsible for providing quality direction and resource support for quality compliance matters impacting the site, including Product Complaints, Inspection Readiness, Annual Product Review, Regulatory and Partner Inspection Management, and Internal Audit Program. 

 

As our AD, Quality Compliance, you will:

  • Oversee the site self-inspection program including, Manufacturing, Packaging, Warehouse, Label Control Storage, Quality Control, Quality Assurance, Engineering, Maintenance, and MS&T to ensure compliance with cGMPs and local procedures.
  • Manage Regulatory Authority and other external compliance audits (e.g. partner audits), including communication and tracking of observations and associated responses.
  • Lead the Inspection Readiness Program for the Cincinnati site.  Assess the compliance status of the site using a risk based approach to assure readiness.  This also includes a review of major/critical observations from other Teva sites and pharmaceutical companies, and implementation of site CAPAs, as appropriate.
  • Serve as site liaison with the regional/global compliance groups for implementation of best practice initiatives, market action decisions, and/or input on new and revised corporate standards/policies.
  • Responsible for completing Annual Product Reviews for product portfolio manufactured and/or packaged at the Cincinnati site. 
  • Coordinate and lead monthly site Quality Councils, and serve as site liaison for quarterly regional Quality Councils.
  • Oversee the Vendor Management program at the site level.  Coordinate inspections/audits through the global audit team.
  • Be responsible for change management and documentation management.  Processing and oversight of changes and documents through the generation, justification, impact assessment, modification, review, approval, and implementation workflows.
  • Review/approve all documentation associated with the establishment and configuration of GMP computerized systems.
  • Identify new and developing trends in cGMPs with potential impact to the site, and serve as a compliance information resource.

Qualifications

 

  • BS/BA in a Science related field required.  MS preferred. 
  • 5+ years in the Pharmaceutical Industry in Quality Compliance/Quality Assurance and/or Operations required.
  • 3+ years in a leadership role required.
  • A minimum of 2 years of experience leading or participating in Regulatory audits required.
  • Understanding of and experience applying principles and practices of internal and external auditing in the pharmaceutical industry, including the use of audit tools and systems-based audits of site operations required.
  • Knowledge of Regulatory Procedure FDA 21 CFR Part 11, with a good understanding of GxP related processes required.
  • Ability to adapt to a fast-paced and dynamic environment.
  • Ability to identify and direct procedural or process improvement to ensure state of compliance.
  • Advocate the value of diversity and foster a culture of collaboration
  • Ability to communicate effectively at all levels in an organization.
  • Highly self-motivated, self-directed, and attentive to detail.
  • Ability to work both independently or as part of a team.
  • Experience leading change management initiatives and identifying areas where teams/departments could improve to be more effective in working through difficult transitions.
  • Ability to establish and maintain collaborative relationships built on trust in order to meet business objectives.
  • Ability to lead continuous improvement programs using Operational Excellence principles to achieve goals and to enable compliant operations.

Function

Quality

Sub Function

Quality Compliance

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 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. 

Categories

Posted: 2021-03-25 Expires: 2021-04-24

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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Associate Director, Quality

Teva Pharmaceuticals
Cincinnati, OH 45202

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