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Job Title: Good Clinical Practice (GCP) QA Reports To: Associate Director/Director- GCP QA Employment Type: Full-time Workplace Type: Remote Timings: Flexible (Upto 2 am IST, few times a week) Travel : International Travel Required (15-45 days duration) THE CELITO TEAM The Celito Team architects the buildout of simplified, integrated, and compliant technology stacks. With both consulting and products, our expertise can help our customers save time and money as they move from strategic Clinical & Quality management all the way to widespread and profitable commercialization. JOB OVERVIEW We are seeking a highly skilled and experienced Senior Manager or Manager of Good Clinical Practice (GCP) Quality Assurance to join our team. This role is responsible for conducting GCP audits, providing consultations, and supporting clinical trial activities for our Research and Development (R&D) division. This role will involve strategic planning and implementation of GCP principles, supporting inspection readiness activities, and leading the Quality Management System (QMS) initiatives. The ideal candidate will possess significant decision-making authority on clinical quality matters and ensure the efficient operation of the QA department. KEY RESPONSIBLIITIES Conduct GCP Audits and Provide Consultations: • Perform on-site and virtual audits of clinical investigator sites, processes, documents, and vendors including CROs, central labs, IVRS, and data management. • 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. Lead GCP Inspection Readiness Activities: • Prepare for and lead GCP inspection readiness activities, including preparation, hosting, and responding to findings from regulatory inspections. • Develop and implement strategies to maintain continuous inspection readiness. Decision Making on Clinical Quality Matters: • Exercise significant decision-making authority on clinical quality matters, including addressing serious GCP breaches. • Provide guidance and recommendations for resolving quality issues. Support Quality Management System (QMS): • Author and review Clinical Quality Assurance (CQA) Standard Operating Procedures (SOPs). • Review and ensure alignment of functional area SOPs with GCP and regulatory standards. Collaboration and Communication: • Work closely with cross-functional teams to ensure alignment and compliance with GCP. • Provide training and mentorship to team members on GCP and quality assurance practices. Continuous Improvement: • Identify areas for improvement in clinical processes and practices. • Develop and implement corrective and preventive actions (CAPAs) to enhance quality and compliance. Leverage International Experience: • Utilize extensive experience working with US and European companies to navigate and comply with varying regulatory requirements. • Facilitate global clinical trials and ensure adherence to multinational GCP standards. QUALIFICATIONS • Master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Medicine). An advanced degree is preferred. • 12- 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. • Extensive experience working with US and European companies. Show more Show less
