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Associate Director, Pharma Quality Compliance

Date: Feb 14, 2021

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!
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:

  • Conduct internal cGMP audits for site operations including, but not limited to, the Manufacturing, Packaging, Warehouse, Label Control Storage, Quality Control, Quality Assurance, Engineering, Maintenance, Manufacturing Science & Technology departments to ensure compliance with cGMPs and local SOPs. You will also carry out auditing responsibilities in accordance with the organization’s policies, procedures, and local, state, and federal laws.
  • Manage Regulatory Authority and other external compliance audits (e.g. partner audits), including communication and tracking of observations and associated responses.
  • Oversee the resolution of issues found during audits/inspections in conjunction with Quality Assurance, Quality Control, Manufacturing, Packaging, Regulatory Affairs, and Supply Chain.
  • Investigate product quality complaints received from global intake center with resolutions including assignment of CAPA, investigation closure, and management of potential field alert actions.
  • Lead the Inspection Readiness Program for the Cincinnati site including assessing the regulatory compliance status of the site with implementation of CAPA to assure compliance. This includes a review of major/critical observations from other Teva sites and pharmaceutical companies, and implementation of site CAPAs, as appropriate.
  • Evaluate all Global Notifications to Management (GNTM) to determine potential impact to the Cincinnati site.
  • Be 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.
  • Manage site corporate standard reviews and associated CAPA to ensure compliance.
  • Identify new and developing trends in cGMPs with potential impact to the site, and serve as a compliance information resource.
  • Advocate the value of diversity and foster a culture of collaboration
  • BS/BA in a Science related field required.  MS preferred. 
  • 10+ years in the Pharmaceutical Industry in Quality Compliance/Quality Assurance and/or Operations required.
  • 4+ years in a leadership role required.
  • A minimum of 3 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 share best practices, and knowledge within and across sites and work with others toward common goals and improved results.
  • Ability to adapt to a fast-paced and dynamic environment.
  • Ability to identify and direct procedural or process improvement to ensure state of compliance.
  • Experience communicating 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.
Sub Function
Quality Compliance
Reports To
In process of validation
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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.

Nearest Major Market: Cincinnati