Job Title: Associate Director, Global Clinical Quality
Location: West Chester, Pennsylvania, United States
Company: Teva Pharmaceuticals
Who We Are
Teva Pharmaceuticals is a global leader dedicated to providing affordable and accessible healthcare. With a strong presence in over 60 countries, Teva is committed to improving lives through its generic medicines, including those on the World Health Organization’s Essential Medicines List. Our goal is to help millions live healthier lives by continuously innovating and delivering quality products.
The Opportunity
Teva Pharmaceuticals is seeking an Associate Director, Global Clinical Quality to join our team. This pivotal role ensures compliance with global Good Clinical Practice (GCP) standards and regulations, leads risk management efforts, and drives continuous improvements in clinical development activities. As a key leader within the Global Clinical Quality department, you will be responsible for implementing quality strategies, managing audits, vendor qualification, and leading regulatory inspection preparations.
Key Responsibilities
Quality Strategy Development
Lead and implement quality strategies for assigned clinical areas.
Develop and maintain an annual audit plan for clinical development activities.
Oversee the vendor qualification process, including audits and risk assessments.
Lead and manage key quality committees like Risk Management Team and Quality Council.
Prepare for and lead regulatory inspections (e.g., FDA, EMA, MHRA).
Leadership and Team Management
Provide leadership in driving compliance across clinical trial activities.
Supervise, mentor, and develop staff within the clinical quality team.
Manage complex compliance issues and lead investigations into clinical trial-related deviations or breaches.
Ensure internal audits and CAPA (Corrective and Preventive Action) processes are executed effectively.
Establish professional competency development programs for the team.
Communication and Stakeholder Engagement
Formulate and lead internal and external communications related to clinical quality matters.
Collaborate with senior leadership and cross-functional teams to influence decisions and drive change.
Address key quality issues and communicate resolutions to senior leadership.
Project and Risk Management
Lead and manage complex, cross-functional projects related to clinical quality.
Monitor and report on key performance indicators (KPIs) related to clinical quality activities.
Proactively identify and mitigate risks to clinical development.
Qualifications and Experience
Education:
Bachelor's degree in a relevant scientific discipline (e.g., Life Sciences, Pharmacy). A Master's degree is preferred.
Experience:
12+ years of experience in the pharmaceutical industry with a strong focus on GCP.
At least 5 years of experience mentoring and managing teams in clinical quality roles.
Proven experience leading complex quality improvement projects and regulatory inspections.
Skills:
Expertise in Quality Management Systems and GCP regulations.
Strong leadership and communication skills with the ability to influence and collaborate with senior stakeholders.
Advanced proficiency in project management and change management.
Experience in audit management and vendor qualification processes.
Other:
International experience and familiarity with various regulatory agencies (FDA, EMA, MHRA) is a plus.
Fluency in English (written and verbal) is required.
Employee Benefits
Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage from the first day of employment (subject to enrollment).
Retirement Savings: 401(k) with employer match, up to 6%, plus an annual 3.75% Defined Contribution to the 401k plan.
Time Off: Paid Time Off (vacation, sick days, holidays) and paid parental leave (if eligible).
Life and Disability Protection: Company-paid life and disability insurance.
Additional Benefits: Employee Assistance Program, Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, and more.
Application Process
To apply, please submit your CV in English. Only shortlisted candidates will be contacted. All personal information will be handled confidentially.
Teva’s Commitment to Diversity
Teva is an equal opportunity employer committed to a diverse and inclusive workplace. We do not discriminate based on age, race, religion, sex, disability, or any other protected status. If you require accommodations during the recruitment process, please inform us in advance.
Make a difference with Teva Pharmaceuticals – apply today!
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