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: EAP, ESPP, tuition assistance, flexible spending/HSA, paid parental leave if eligible, etc. Application instructions Apply through Teva’s internal career site on Twist. #J-18808-Ljbffr Scorpion Therapeutics