1+ months

GMP Compliance Manager--Americas Regional Compliance

Parsippany, New Jersey
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 perform Compliance related activities that support the approximately 20 sites in the Americas Region (Canada, US, Latin America) including oversight for the development and maintenance of quality processes that ensure compliance with established standards and agency guidelines as well as tracking, trending and reporting on the processes listed. You will be the main point of contact between  quality and manufacturing sites.

 

Key  Responsibilities     

  • Lead regional programs and projects using structured methodologies, in order to deliver their on-time, on-budget, expected results.
  • Provide support to sites/units in the region, including projects, processes, and metrics
  • Facilitate Americas region adherence to corporate standard requirements through distribution of drafted and approved standards, performing an intra-region analysis for submitting a singular perspective from the region, and providing forums to assist sites in closing identified gaps.
  • Conduct gap assessments for corporate standards and resolve gaps for the Americas Region Compliance Support Department.
  • Collects, aggregates and analyzes data from multiple internal sources and reports patterns, insights and trends. The goal is to support data-driven insights into business performance and opportunities for improvement  
  • Assists manufacturing sites in implementing inspection readiness program and verifying readiness.
  • Provides on-site support to Teva sites for regulatory inspections, GRA, and third party audits as needed.
  • Oversees gap analysis against observations to prevent repeat observations at other Teva sites.
  • Insure the effective, efficient, and compliant execution of the Critical event lifecycle elements associated with Notification to Management (NTM), Field Alert Reporting (FAR), Quality Alignment Meetings (QAM), and Market Action Committee (MAC).
  • Partner with manufacturing sites to ensure timely internal communication for all elements of a critical event, supports investigational process for critical events, and facilitates the incident to resolution.

 

Qualifications

 

  • Bachelors degree in Biology, Chemistry, Microbiology, or related science or equivalent combination of education and experience
  • Quality Assurance/Quality Control professional certification desirable
  • Minimum  5 years related pharmaceutical industry Quality Assurance/compliance experience is required
  • A solid understanding and  strong working knowledge of GMPs,  FDA Regulatory Guidelines, Quality System requirements  and Standard Operating Procedures is a must
  • Direct on-site pharmaceutical manufacturing experience within the last 5 years is preferred
  • Quality System Administration experience preferred
  • Experience conducting audits and writing responses preferred
  • Must be proficient with all quality standards and compliance requirements
  • Must be able to travel 25% to 30% (domestic and international)

 

Function
Quality
Sub Function
Quality Compliance
Reports To

Senior Director, Americas Regional Compliance Support

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: 2019-11-05 Expires: 2020-01-03

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.

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GMP Compliance Manager--Americas Regional Compliance

Teva Pharmaceuticals
Parsippany, New Jersey

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