Teva Associate Director Global Clinical Quality 

United States, Pennsylvania, East Bradford Township 

183106635

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.

• 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.

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, supporting and developing others
• Continuous professional development, as evidenced through increasing knowledge, expertise and responsibility.
• Ability to work with various organizational leadership levels and in a team environment across multiple roles, multi and Intercultural sensibility.
• Advanced experience in working with matrix environment.
• Advanced English communication skills – written and verbal.
• Regulatory inspections (FDA, MHRA, EMA, etc.) a plus.

Functional / Industry Knowledge:

• Expertise in relevant GCP and direct experience working with advanced knowledge Quality Management Systems.
• Advanced knowledge of local current and upcoming legislation and current Quality best practices.
• International experience is an advantage.
• Advanced ability to understand, interpret, and execute in accordance the Teva Quality Management System.
• Advanced knowledge in Auditing.
• Advanced knowledge in Quality Oversight.
• Demonstrated skill in effective written and verbal communication, collaboration/negotiation skills and proven record of influencing and implementing change are required.

Critical Capabilities:

• Advanced knowledge in Problem Solving.
• Energetic, committed to continuous improvement.
• Effective negotiation skills, strong interpersonal skills, excellent presentation skills.
• Strong project and change management.
• Proactive orientation, self-motivated, flexible, and innovative way of thinking.
• Addresses multiple site issues in a timely manner.
• Effectively adjusts plans to meet changing needs of priorities.
• Applying a Strategic Approach.
• Makes the right short-term decisions without sacrificing long-term results.
• Integrates input from different areas together and balances all competing demands based on wide and long-term understanding on the business needs.
• Holds a broad perspective and understanding of processes and translates this understanding into Quality terms (and vice versa).
• Translates business & industry trends and regulatory standards into business imperatives.
• Applies knowledge of industry's best practices to provide inputs for increasing operational productivity within assigned area of work.

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, 13 paid Holidays and 3 paid floating holidays.
• 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.

Director, Clinical Quality Assurance

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