1+ months

Senior GMP Compliance Manager - Americas Regional Compliance

Parsippany, NJ 07054
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 support GMP Regulatory Compliance activities at multiple sites in the Americas Region--Canada, United States, and Latin America). You will interact with and provide support to both global quality and manufacturing sites. Your responsibilities will include providing oversight for the development and maintenance of quality processes that insure compliance with established standards and agency guidelines. 

 

Key Responsibilities

Americas Region Liaison

  • Facilitate the roll-out of global projects and programs in the Region acting as liaison between sites and global units
  • Facilitate best practice and knowledge sharing activities

Quality Systems & Compliance

  • Assess site Compliance / Quality Systems and work with the site on required improvements.
  • Spend time in the operations and laboratory in order to understand site challenges and areas of improvement to provide support.
  • Corporate Quality Standards - Facilitate distribution and gap assessment; provides forums to assist sites in closing identified gaps.
  • Global Notification To Management (NTM) Facilitate processes (Distribution, Monitoring, Consolidation) acting as the liaison between the Global NTM Coordinator and Site Quality

 Performance Management (Metrics)

  • Aggregate and analyze 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

Inspection Readiness and Inspection Management

  • Regular on site visits to Teva manufacturing sites to assist manufacturing sites in inspection readiness activities, execution, response, and remediation
  • Support the site during regulatory inspections as required
  • Facilitate gap analysis for observations from regulatory agencies

Field Alert Events

  • Support investigational process for critical events, and facilitates the incident to resolution, including review of FAR/ BDPR/MDR and review of critical investigations
Qualifications
  • BS degree in Biology, Chemistry, Biochemistry, Microbiology, or related scientific discipline or equivalent combination of education and experience
  • Minimum 7 years related pharmaceutical industry Quality Assurance/compliance experience supporting quality and manufacturing sites
  • Direct on-site pharmaceutical manufacturing experience within the last 5 years is preferred
  • Experience interacting with people at all levels of the organization leveraging strong communication, negotiation and influence skills 
  • Experience handling multiple tasks and priorities simultaneously required
  • Deep working knowledge of FDA Regulations and GMPs and quality system requirements
  • Quality System Administration experience is preferred
  • Experience with conducting audits and writing responses desirable
  • Must be able to travel 30% of the time--Domestic with possibility of Latin America
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: 2019-08-12 Expires: 2019-12-15

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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Senior GMP Compliance Manager - Americas Regional Compliance

Teva Pharmaceuticals
Parsippany, NJ 07054

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