Lead the Clinical Quality Assurance (CQA) team in the plan, execution, and analysis of internal and external audits for the organization, with direct report to the Vice Present of Quality Assurance. Ensure the plan, coordination, control, and continuous improvement of both processes and methods to assure the quality of trials, studies, and pharmacovigilance at The Company. Lead a team focused on quality assurance for Clinical Research and Development, Pharmacovigilance, Clinical Regulatory Affairs, and Medical Affairs for activities related to the branded and generic products, and all divisions of the company
Essential Duties and Responsibilities
Leadership of a four-member team focused on clinical quality assurance and compliance-related activities.
Refine and maintain Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) aligned with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) compliant processes.
Strong leadership skills and commitment to a team-based organization.
Actively lead audit activities in the areas of internal quality audits, Corrective and Preventive Actions (CAPA), production support, quality management reviews, and agency regulations.
Assist team suitable recommendations and root cause analyses techniques aligned with continuous improvement initiatives
Qualifications and Requirements
Baccalaureate of Science/Arts or higher degree, preferably in biology, health-related sciences, or organizational management.
Eight or more years in the pharmaceutical industry, inclusive of the performance of internal and external audits.
Regulatory experience preferred.
Prior role in inspections by the United States Food and Drug Administration preferred.
Demonstrable strong analytical and problem-solving skills.
Strong written and verbal communication skills, along with proficient computer skills.
Ability to work overtime as needed.
Physical Environment and Physical Requirements