Senior Director, Clinical Quality Assurance

Essential Functions: Responsible for leading the Clinical Quality team, which includes third-party and internal auditing and day-to-day clinical study team support. Reviews and approves internal and external audit reports, Quality Events and associated Corrective and Preventative Actions within ProPharma's QMS, Dot Compliance. Represents Clinical Quality expertise across the organization. Keeps current with global health authority laws and regulations; identifies gaps and implements process improvements resulting from new/revised regulations or guidance. Reviews study team and regulatory documentation as requested (e.g., Data Management, Operations, Safety, Regulatory, etc.). Leads external Health Authority inspections and audits, as needed. Provides guidance in global regulatory reporting requirements (e.g., serious breach, etc.). Contributes to Clinical components of a global inspection readiness program. Other duties as assigned. Necessary Skills and Abilities: Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization to provide solutions to complex situations. Must be strategic as well as a hands-on leader who can see 'the big picture' while providing guidance to execute daily tasks. Must have experience in managing a team of QA professionals. Demonstrated Quality Management System experience appropriate for clinical development. Proficient in risk management principles. Self-motivated with the ability to work effectively in a dynamic environment. Excellent critical thinking and problem-solving skills and strong collaborator. Works well with clients and internal colleagues. Ability to effectively manage multiple priorities with a sense of urgency. Educational Requirements: Bachelor's degree. Experience Requirements: Ten (10) or more years' experience working in clinical development, preferably in either clinical compliance or Clinical Quality Assurance. Strong knowledge of global clinical trial regulations (e.g., ICH, FDA, etc.) and guidelines, particularly in GCLP, CAP, CLIA and GCP. Demonstrated understanding in third party/internal Quality audits, Issue Management and CAPA in a clinical environment. Experience leading FDA or other Health Authority Inspections.