1+ months

Site Quality Leader--Florida Operations

Davie, FL 33314
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

Job Description

 

Position Summary

You will insure that a Quality Management System is in place, securing compliance of activities and supporting continuous improvement.

 

Key Responsibilities

  • Lead Quality Regulatory Compliance-- Provide guidance to site managers and employees, conduct internal and support external audits, to ensure compliance with Teva's global standards, regulatory guidelines and cGMP requirements
  • Assess and Mitigate Risks-- Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply
  • Design and Implement the Site Quality ProgramCollaborate with the Site GM and Corporate Quality to create, implement, monitor and update the site quality program.
  • Manage Quality Data--Oversee the delivery of necessary data to site managers and supervisors, Corporate Quality and other  internal and external stakeholders,  to support the achievement of Quality objectives and ensure compliance
  • Direct Quality Control-- Oversee the laboratory activity, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products for the site
  • Promote a Sustainable Culture of Quality---Create, develop and maintain a culture of enhancing quality throughout the entire site operation.  Create a space where people can speak openly and are encouraged to present new ideas to improve quality
  • Strategic partner with Supply Chain, Project Management, R&D and Commercial to ensure project timelines and objectives are met
Qualifications

 

Education

  • Bachelors degree in a technical, life sciences, or business discipline required
  • Quality and/or Supply Chain Professional certifications desirable (e.g., CQA, CSCP, CPIM)

 

Key Requirements

  • Minimum of 12 years pharmaceutical manufacturing site quality operations and leadership experience,  including:   
    • Expert understanding of packaging, technology transfer, cGMPs, FDA, EU, ICH guidelines as well as CMC content of regulatory submissions,   
    • Deep knowledge of chemical/pharmaceutical production operations/ lifecycle, production scheduling, production equipment/ validation and relevant technologies and product types,   
    • Experience launching  new products in a commercial setting,
    • Experience participating in pre-approval inspections by FDA and other regulatory agencies,
    • Deep knowledge of cGMP requirements for products and process, and
  • Deep knowledge of Quality Systems
  • Experience supervising large teams and leading Project Management Teams
  • Experience developing and implementing new, efficient, and effective business processes
  • Must have adequate knowledge of Quality best practices
  • Must have adequate practical knowledge of pharmaceuticals manufacturing and control
  • Must have adequate practical knowledge of analytical techniques and microbiological principles
  • Must have adequate knowledge of product types or profile codes/ classes
  • Must have a basic knowledge of chemical/pharmaceutical cross functional operations (e.g., Supply Chain, Engineering), product and tech transfer
  • International experience is desirable but not required

 

Function
Quality
Sub Function
Quality Assurance Methods
Reports To

Senior Vice President, Quality--Americas Technical Operations

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: 2019-11-01 Expires: 2019-12-24

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.

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:

Site Quality Leader--Florida Operations

Teva Pharmaceuticals
Davie, FL 33314

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast