Associate Director, Global Clinical Quality

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

As a leader in the Global Clinical Quality department, serves a critical role to ensure compliance with global Good Clinical Practice (GCP) guidance, laws, and regulations, supports risk management activities, and leads continuous improvement for clinical development activities.   The Associate Director – Global Clinical Quality leads a portfolio of work related to quality aspects of clinical development activities, developing and implementing the quality strategy for the assigned area and leads/assigns staff/supervises support for routine/complex activities. The Associate Director – Global Clinical Quality must have strong communication skills in order to direct and/or advise quality staff, stakeholders, management and senior leadership.

How you’ll spend your day

• Develop and implement the quality strategy for the assigned area. Examples may include but not limited to:
  • Independently lead annual audit plan development and maintenance for the assigned area.
  • Lead vendor qualification process, including risk assessments and related activities, i.e., vendor audits, quality agreements approval.
  • Lead Committees such as Risk Management Team, Quality Council.
  • Lead inspection preparation and inspection activities.
• Act and behave in accordance with Teva’s values and leadership standards
• Formulate and lead communication within the department, and to relevant stakeholders and senior leadership.
• Lead/assist in preparation for and conduct of regulatory inspections. Review inspection responses from the business. Follow-up on inspection commitments.
• Lead to resolution complex compliance issues that may affect multiple projects.
• Independently review/audit clinical trial related documents.
• Complete training and qualification requirements of role, as assigned.
• Ensures the work is completed in compliance with relevant regulatory requirements.
• Formulate the plan for internal functional/departmental system audit, perform/assign the audit and review/approve audit documentation. Oversee CAPA implementation and effectiveness if relevant.
• Act as a subject matter expert on complex quality issues, as needed.
• Oversee/lead in Quality Event/deviation investigation, serious breach assessment where applicable, data privacy issues where applicable, root cause analysis, and CAPAs management. Follow-up until conclusion.
• Collect, present, and/or analyze metrics and KPIs related to unit activities. Identify gaps/risks in the business.
• Independently plan, lead and deliver assigned complex and/or cross-functional projects. Lead/assign staff/supervise support for projects and routine/complex activities.
• Support the Director in the development of departmental priorities for studies, audits, inspection preparation activities, etc., and manage/lead their implementation. Provide Director with regular status updates. Escalate significant issues in timely manner.
• Work with indirect subordinates, mentor/manage staff to develop quality skills and oversee deliverables, as needed. Set the strategic vision for and lead the team. Set an example for a safe and engaged working environment. Plan, assign and direct work; address issues and provide solutions. 
• Identify opportunities and develop plans for formal and informal professional competency development, learning and knowledge sharing to increase productivity and performance.
• Responsible for training and qualification of the team and ensure that the required initial and continuing training is carried out and adapted according to need.

Travel Requirements:  

• May require up to 25% domestic and international travel.

Your experience and qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. 

• Bachelor’s degree in relevant science is required. Master's Degree preferred.
• 12+ years of pharmaceutical industry experience, including GcP knowledge.
• 5+ years of experience in a role mentoring