Head of Global Quality R&D

Responsibilities:
- Define and execute the global R&D Quality strategy; ensure alignment with Global Quality, Regulatory, CMC, and R&D leadership.
- Establish and oversee quality governance structures across all R&D functions.
- Ensure end-to-end GxP compliance across R&D (GLP, GCP, GMP for clinical supplies).
- Provide quality oversight for preclinical/non-clinical studies (conduct, documentation, CRO oversight).
- Oversee quality for clinical development activities (protocols, study execution, monitoring, data integrity).
- Ensure compliance with ICH guidelines and global regulatory requirements across early research, translational activities, and clinical programs.
- Provide QA oversight of IMP manufacturing, packaging, labeling, release, and stability programs (with CMC/Technical Development).
- Manage deviations, CAPAs, change controls, and batch disposition processes for clinical supplies.
- Lead preparation and response for global regulatory inspections; represent Quality with authorities.
- Ensure data integrity and quality/compliance of R&D data (labs, clinical databases, digital systems).
- Own R&D Quality Systems (document control, training, audit management, deviations/CAPA, change control).
- Oversee qualification, auditing, and ongoing monitoring of CROs, CDMOs, central labs, and third-party vendors.
- Lead global R&D internal audit programs.
- Implement and maintain Quality Risk Management aligned with ICH Q9/Q10.
- Identify systemic risks impacting data, patient safety, regulatory compliance, or technical development; lead mitigation.
- Drive continuous improvement and strengthen quality culture, operational efficiency, and scientific robustness.
- Ensure inspection readiness via proactive quality reviews, mock inspections, and compliance training.
- Promote quality culture and scientific integrity; ensure EHS&S mindset and proactive safety risk management.
- Lead, mentor, and develop a high-performing global team.

Qualifications / Skills:
- BS degree in Science/Life Sciences/Engineering/Pharmacy or related.
- Minimum 15 years’ pharmaceutical R&D experience in a large pharma company.
- Practical knowledge of global compliance/regulatory requirements and cGxP (e.g., US FDA, EMA).
- Direct interaction experience with health authorities.
- Experience establishing and maintaining Quality Management Systems (QMS) across R&D.
- Experience in large, complex matrixed environments with global governance; practical pharma R&D knowledge.
- Ability to develop and execute Strategic/Long Range and Annual Business Plans.
- Practical knowledge of risk management.
- Strong critical thinking/problem-solving; strategic thinking.
- Excellent storytelling/presentation; cross-functional collaboration and stakeholder management; effective communication.
- Strong leadership, change management, influencing, and decision-making under uncertainty.
- Proven talent management/people development (coaching/mentoring); ability to manage organizational complexity.

Benefits:
- Comprehensive Health Insurance (medical, dental, vision, prescriptions).
- Retirement Savings: 401(k) with employer match (up to 6%) and annual 3.75% Defined Contribution.
- Paid Time Off (vacation, sick/safe time, caretaker time, holiday).
- Company-paid Life and Disability insurance.
- Additional benefits listed in the posting (e.g., EAP, ESPP, tuition assistance, flexible spending/HSA, paid parental leave if eligible, etc.).

Application instructions:
- Apply through Teva’s internal career site on Twist.