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Associate Director Quality Compliance CMSO

Date: Sep 10, 2022

Location: Parsippany, New Jersey, US, 07054

Company: Teva Pharmaceuticals

Who are we?

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

The main purpose of your job will be to ensure that a Complex Manufacturing & Supply Operations (CMSO) Quality Compliance System is in place, securing the compliance of activities, quality risk management, escalation of risks, and continuous improvement. Your role will include strong collaboration with manufacturing site operations to foster excellence in inspection management and inspection readiness at Teva sites and to improve sterility assurance. You will also interact across the matrixed organization specifically with Teva Global Quality Compliance, Manufacturing Science & Technology, Research & Development, Supply Chain Operations, and other network manufacturing supply sites.

You will collaborate with the CMSO sites to improve and enhance GMP compliance, solve quality-related product and system issues, including those related to sterility assurance, and identify areas of improvement for quality operational performance in accordance with Teva standards. Moreover, you will contribute to onsite Quality culture across the CMSO segment.

 

Processes and Outputs

  • Engage in Corporate Standards Processes
  • Input, Review, and Endorsement of Complex Investigations
  • Support the Implementation of the Site Inspection Readiness Program
  • Evaluate and Endorse the Site Inspection Readiness Program
  • Notification of Escalation to Regulators; i.e. Field Alert Reports (FARs) and Rapid Alert Notifications (RANs)
  • Support the development of the Global Risk Assessment (GRA) Audits Corrective and Preventive Action Plan (CAPA)   
  • End-to-End Process Support for Health Authority Inspections  
  • Support the Implementation of Quality Risk Management
  • Participate and Evaluate Site Quality Council Performance Data and Areas of Risk
  • Prepare, Evaluate, and Discuss Performance Data at the CMSO Quality Council
  • Support the assessment and improvement of data integrity management

Qualifications

 

Formal Education

  • Bachelor's Degree – chemistry, microbiology, pharmacy, engineering, or related science-based degree.

 

Practical Knowledge and Experience

  • Microbiology/Sterility Assurance experience
  • Data Integrity management experience
  • Experience 12+ years of experience working in a manufacturing site, within Quality and/or Compliance, with extensive exposure to site operations. Experience working with technical and operational teams troubleshooting a plus
  • Adequate knowledge of local current and upcoming legislation and current Quality best practices. International experience is an advantage
  • Advanced knowledge of cGMP requirements for products and process
  • Advanced understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Documentation, etc.
  • Adequate knowledge of MRP Systems and GMP computer systems
  • Adequate experience in working with matrix environment
  • Adequate knowledge of Auditing
  • Advanced communication skills – written and verbal
  • Advanced teamwork skills
  • Must travel regularly (domestic and international); target 30%

 

Professional Competencies 

  • Advanced negotiation skills, strong interpersonal skills, excellent presentation skills
  • Adequate project and change management
  • Ability to work with various organizational leadership levels and in a team environment across multiple roles
  • Excellent and effective verbal, written communication skills and interpersonal skills
  • Adequate experience in Compliance and Health Authority interaction. Working knowledge of audit and inspection management, response writing and CAPA management programs required
  • Energetic and committed to continuous improvement to evolving compliance expectations
  • Proactive orientation, self-motivated, flexible, and innovative way of thinking
  • Intercultural sensibility

Function

Quality

Sub Function

Quality Compliance

Reports To

Sr Director Quality Compliance CMSO

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 opportunities 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.

 

Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations.


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