Share this Job

Senior Manager Quality Professional

Date: Feb 12, 2019

Location: Great Valley, US, 19355

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

Major duties and responsibilities:

  • Develop and manage assigned theraputic area quality audit program
  • Independently manage Clinical Quality Assurance (CQA) activities of a study or project including planning, scheduling and conducting investigational site audits and TMF audits
  • Independently review/audit clinical trial related documents
  • Independently plan, schedule and conduct or leads a team in full Contract Research Organization (CRO), and vendors audits, based on the primary role
  • Lead the development, review, approval and distribution of global SOP, Work Instructions, forms and templates
  • Oversee the development of Audit Plans for clinical trial developed by CQA staff  
  • Conduct GCP training programs and execute the associated training documentation
  • Lead internal system/process audits
  • Independently performs or leads For Cause Audits
  • Lead the preparation for and during a regulatory inspection
  • Lead or assist in investigations to determine root cause analyses for CQA CAPAs 
  • Lead or assist in managing any of the following areas based on the assigned role: product complaints, serious breach, CAPAs and/or Quality Council
  • Participate and attend assigned study teams meetings and to provide study team direct oversight and guidance, advising on major compliance issues with guidance from management
  • Contributes to process improvements
  • Mentor junior staff in the accomplishment of their assigned duties

Other projects and duties as required/assigned by direct manager

Qualifications

Education and Knowledge Requirements:

Requires a college or university degree or the equivalent work experience that provides working knowledge of GCPs / ICH / EU Directives/FDA/ etc. is a requirement.

Requires GxP related knowledge and experience of 5+ years; acquiring higher level knowledge and skills of the organization, processes and customers

 

Travel

Require to travel up to 6 site audits (2-days audit) per quarter

Function

Quality

Sub Function

R&D Quality

Reports To

Director of Quality

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: Philadelphia