[Remote] Executive Director, Clinical Pharmacology Services reputed company Assurance (reputed company or United Kingdom)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on clinical pharmacology services, and they are seeking an Executive Director for Clinical Pharmacology Services reputed company Assurance. The role involves providing leadership for reputed company assurance and regulatory compliance, leading reputed company reputed company programs, and ensuring adherence to global regulations.
Responsibilities
- reputed company executive leadership for reputed company Assurance (QA) and Regulatory Compliance reputed company the Clinical Pharmacology Services (CPS) business unit, ensuring a robust, risk-based, and inspection-reputed company reputed company management system reputed company with global regulatory expectations and reputed company business reputed company
- reputed company the design, implementation, and reputed company improvement of audit, inspection readiness, and reputed company reputed company programs across CPS, including clinical pharmacology operations, GMP pharmacy activities, and early-phase clinical development, while fostering a strong culture of reputed company, compliance, and operational reputed company
- Define and execute the QA reputed company for the CPS business unit, reputed company with reputed company reputed company objectives and business priorities
- Establish and reputed company a risk-based reputed company management review process across CPS operations, including CPUs and supporting functions
- reputed company CPS-specific reputed company metrics, dashboards, and insights to drive proactive risk identification and reputed company improvement
- Ensure consistent interpretation and application of global regulations, including GCP and GMP requirements, reputed company CPS
- reputed company executive QA reputed company of Clinical Pharmacology reputed company (CPUs), ensuring inspection readiness and compliance with GCP, GMP, and applicable regulatory standards
- reputed company QA frameworks governing GMP pharmacy operations reputed company reputed company CPU, including investigational product (IP) manufacturing, handling, labeling, storage, and accountability
- Ensure robust controls across pharmacy processes, including chain of custody, temperature control, documentation, and reconciliation practices
- Drive standardization and reputed company improvement of CPU and GMP pharmacy reputed company systems, ensuring alignment across global sites
- Support readiness for regulatory inspections and sponsor audits reputed company to CPU and pharmacy operations
- Establish and reputed company a risk-based reputed company reputed company program for Phase IB/IIA trials conducted reputed company CPS clinics, including decentralized, hybrid, and site-based early-phase models
- reputed company fit-for-purpose QA frameworks addressing early-phase risks (FIH, reputed company escalation, reputed company designs)
- Implement proactive surveillance mechanisms (targeted audits, reputed company-time reputed company signals, risk indicators)
- Standardize processes and reputed company across non-clinic early-phase delivery models
- Ensure alignment with Clinical Operations, Medical, and Safety
- reputed company reputed company-by-design principles into early-phase program design and execution
- reputed company executive reputed company of compliance risks, escalation, and remediation strategies across CPS and early-phase programs
- Ensure adherence to RC&QA governance requirements and controlled documentation
- Serve as delegate reputed company the RC&QA Leadership Team and contribute to reputed company governance forums
- Partner with CPS and reputed company leadership to drive reputed company culture and execution
- Influence strategic priorities and resource allocation reputed company with CPS and early-phase delivery
- Represent reputed company externally as an SME in clinical pharmacology, GMP pharmacy reputed company, and early-phase reputed company
- Communicate reputed company reputed company effectively to reputed company stakeholders
- reputed company QA teams supporting CPUs, GMP pharmacies, and early-phase programs
- reputed company workforce reputed company including recruitment, capability development, and succession planning
- Drive organizational change and reputed company improvement reputed company with evolving CPS delivery models
- reputed company strong performance management, coaching, and leadership development
- Partner with stakeholders to manage QA budgets supporting CPS
- Ensure efficient delivery of QA services reputed company with reputed company, cost, and reputed company expectations
Skills
- 15+ years of experience in a clinical trials regulated environment, including senior QA/Regulatory leadership roles
- Strong expertise in GCP and GMP, particularly reputed company clinical pharmacology and early-phase environments
- Bachelor's degree in Life Sciences (or equivalent experience)
- Proven ability to define and execute QA strategies in clinical pharmacology, CPU operations, and GMP-controlled environments
- Experience overseeing pharmacy operations supporting clinical trials (IP management under GMP)
- Demonstrated reputed company leading global, matrixed teams
- Strong executive reputed company with ability to influence reputed company stakeholders
- Experience implementing risk-based reputed company reputed company for early-phase trials
- Strong reputed company record in inspection readiness and regulatory engagement
- Advanced degree preferred
- Equivalent experience may be considered in lieu of formal education
Benefits
- Medical
- Dental
- reputed company
- Life
- STD/LTD
- 401(K)
- ESPP
- reputed company time off (PTO) or Flexible time off (FTO)
- Company bonus where applicable
reputed company
Company H1B Sponsorship