1+ months

Director, Quality Assurance

Davie, FL 33314
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 Davie and Sunrise (Florida) production sites are two of our largest launch facilities.   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!

 

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
  • As a Director Plant/Site Quality Assurance, well count on you to:
  • Manages all the Quality Assurance 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.

     

    ESSENTIAL AREAS OF RESPONSIBILITY

     

    • 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 manufacturing and  packaging 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 Quality Assurance team including answering complaint calls, creating and tracking complaint records, liaison with manufacturing sites, reviewing investigations, issuing closing letters, monitoring complaint analytics and trends and department performance metrics.
     

     

     

     

Qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

 

Education/Certification/Experience:

 

  • Requires Bachelors in Biology, Biochemistry, Microbiology, Pharmacy or equivalent with a minimum of 10+ years relevant progressive experience in the pharmaceutical industry. 
  • Solid understanding and knowledge of GMPs and Regulatory Guidelines. 
  • 7+ years of supervisory experience in leading people.
  • Knowledge of Complaint Evaluations, Batch Records and Investigations required.
  • FDA regulations, GMPs, SOPs

 

Skills/Knowledge/Abilities:

  • Ability to work and lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving department and site goals.
  • Demonstrated experience in the launch of new products in a commercial setting.
  • Self-motivated and able to work independently and be reliable and responsive.
  • Requires expert understanding of packaging, technology transfer, cGMPs, FDA, EU, ICH guidelines as well as CMC content of regulatory submissions.
  • Superior communication skills, both written and verbal.
  • Demonstrated success in participating in pre-approval inspections by FDA and other regulatory agencies.

 

Problem Solving:

  • Previous experience with pharmaceutical industry complaints, call center management and Field Alerts along with Trackwise system experience is a plus
  • Strong conflict management and negotiation skills.
  • Must have hands on experience in managing diverse project activities with a pharmaceutical drug product manufacturing facilities at different geographical locations

 

 

 

Function
Quality
Sub Function
Manufacturing Quality Assurance
Reports To

Sr Director of Quality

Tevas 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.

Categories

Posted: 2019-10-29 Expires: 2020-01-13

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.

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Director, Quality Assurance

Teva Pharmaceuticals
Davie, FL 33314

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast