Teva Senior Director Quality R&D 

United States, New Jersey 

727653446

• Leading and managing all quality activities in R&D, ensuring compliance with GLP, GCP, and CMC standards.
• Overseeing Quality Compliance processes and supporting Teva R&D development centers and suppliers.
• Ensuring inspection readiness and successful authority inspections.
• Leading the R&D Compliance, Sterility Assurance, and Microbiology teams.
• Building and managing infrastructure to improve Quality relations with external suppliers.
• Collaborating cross-functionally with Operations, Commercial, R&D, RA, MS&T, Supply Chain, Engineering, Procurement, and more.

Education:

• BS Degree in Science, Life Sciences, Engineering, Pharmacy, or related field.
• Advanced degree in Chemical Sciences preferred.
• Advanced training in pharmaceutical technology.

Experience:

• Minimum of 15 years in the pharmaceutical industry.
• Significant management experience, such as Site Quality Head or Site General Manager.
• Extensive experience in pharmaceutical operations, including manufacturing, packaging, testing, release, development, and registration of pharmaceuticals.

Technical Knowledge:

• Industry-related certifications desired but not required (e.g., Pharma, Compliance, Regulatory affiliations).
• Significant knowledge of Global Compliance and Regulatory requirements.
• Familiarity with industry guidelines (e.g., ICH guidelines) and cGxP standards (Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice).
• Understanding of regulations from supervisory authorities (e.g., US FDA, EMA, AIFA, IL MoH, Russian MoH, Indian FDA).
• Experience with Quality Management Systems (QMS) implementation and continuous improvement.
• Proficiency in managing inspection readiness, deviation investigations, and CAPA (Corrective and Preventive Actions) processes.
• Knowledge of Operational Excellence methodologies and capacity planning.

Critical Capabilities:

• Strong transformational leadership and influence in a global environment.
• Ability to manage cultural diversity.
• Crisis and Risk Management capabilities.
• Proficiency in planning and organizing.

Travel Requirements:Willingness to travel up to 50% to manufacturing and R&D sites, HQs, and other required meetings.

West Chester, PA or Parsippany, NJ

We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 11 paid Holidays and 1 paid floating holidays.
Posting a new req-2024
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

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