Role Overview We are seeking an experienced professional to fill the role of Senior Good Clinical Practice Quality Assurance Specialist. The successful candidate will be responsible for conducting audits, providing consultations, and supporting clinical trial activities within our Research and Development division. Key Responsibilities 1. Conduct GCP Audits And Provide Consultations 2. Perform on-site and virtual audits of clinical investigator sites, processes, documents, and vendors including CROs, central labs, IVRS, and data management. 3. Offer expert consultations and clinical trial support to R&D; teams. Serve in an Advisory Role for R&D;: - Advise Clinical Operations, Clinical Development, Statistics, Programming, Regulatory Affairs, Pharmacovigilance, and other R&D; functions. - Review and provide feedback on clinical documents including protocols, consent forms monitoring plans, and data management plans. - Quality Assurance Activities - Oversee quality assurance activities related to clinical, bioanalytical, diagnostic, safety, and pharmacokinetics analyses of clinical studies. - Ensure all activities comply with GCP guidelines and regulatory requirements. Leadership Responsibilities 1. Lead GCP Inspection Readiness Activities 2. Prepare for and lead GCP inspection readiness activities, including preparation, hosting, and responding to findings from regulatory inspections. 3. Develop and implement strategies to maintain continuous inspection readiness. 4. Decision Making on Clinical Quality Matters 5. Exercise significant decision-making authority on clinical quality matters, including addressing serious GCP breaches. 6. Provide guidance and recommendations for resolving quality issues. Qualifications A Master's or bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, Medicine). Advanced degree preferred. Minimum of 15+ years of experience in clinical research quality assurance or a related field. Extensive knowledge of GCP guidelines and regulatory requirements. Proven experience in conducting GCP audits and inspections. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to work independently and as part of a multidisciplinary team. Certification in GCP or related areas is a plus.