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Assoc Dir, Quality Assurance

Date: Jan 13, 2021

Location: Irvine, California, US, 92618

Company: Teva Pharmaceuticals

Company Info

If you’re like people at Teva, you dare to be different. We’re 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.
Teva’s Irvine, CA production site is one of our complex 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 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 AD, Quality to join our team in Irvine, CA!

The position provides QA review and approval of new and existing methods/procedures, validation/transfer protocols, investigations, corrective/preventive action plans and change control documents. This position also participates as an SME in external and internal audits of operational areas, provides support, direction and representation for quality management as a decision maker.

You will:

  • Be responsible for the daily management and development of direct reports.
  • Support the development and execution of validation protocols for equipment, processes, products, and affected facility or utility areas.
  • Provide a thorough, timely review and approval of cGMP documents and processes such as those related to validation, change control documentation, deviations, investigations, qualification, protocols and reports, facility controls, instruments and procedures.
  • Provide QA support and/or review and approval of Annual Product Reviews, Continuous Process Verification and Risk Assessments
  • Act as an SME and participating directly in internal/external audits.
  • Actively support and manage partner relationships, and interact with onsite Senior Leadership Team.
  • Work with operating departments to facilitate process improvements and lean concepts.
  • Make sure team maintains 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.
  • Ensure that you and your team complete all training requirements and maintain 100% compliance with all assignments.  
Qualifications
  • BS in Science-related discipline required.
  • 10 years of Quality experience in Pharma, Medical Device or Biologics required.
  • Comfortable presenting to Sr. Leadership Team.
  • Experience reviewing, signing CAPAs and Deviations and managing quality process with other departments in order to meet timelines.
  • Must have lab background.
  • Must be detail oriented with ability to analyze information and create corresponding performance metrics.
  • Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases required.
  • Ability to demonstrate sound judgment and decision-making required.
  • Ability to motivate, influence and lead others with and/or without direct supervisory authority and ability to build and maintain collaborative relationships between teams, departments and business units.
  • Ability to communicate effectively with excellent written and oral communication skills.
  • Manage conflict and negotiate resolution.
  • Self-directed with ability to organize and prioritize work.
  • Project management and advanced presentation skills preferred
Function
Quality
Sub Function
Manufacturing Quality Assurance
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: Irvine California
Nearest Secondary Market: Los Angeles