Senior Good Clinical Practice QA USD K Month CLT Join to apply for the Senior Good Clinical Practice QA USD K Month CLT role at Netvagas. Job Overview Our client is seeking a highly skilled and experienced Senior Manager or Manager of Good Clinical Practice (GCP) Quality Assurance to join our team. This role involves conducting GCP audits, providing consultations, and supporting clinical trial activities within our Research and Development (R&D;) division. The responsibilities include strategic planning, implementation of GCP principles, supporting inspection readiness, and leading Quality Management System (QMS) initiatives. The ideal candidate will have significant decision-making authority on clinical quality matters and ensure the efficient operation of the QA department. Key Responsibilities - Conduct GCP audits and provide consultations to R&D; teams, including on-site and virtual audits of clinical investigator sites, processes, documents, and vendors such as CROs, labs, IVRS, and data management. - Review and give feedback on clinical documents like protocols, consent forms, monitoring plans, and data management plans. - Oversee quality assurance activities related to clinical, bioanalytical, diagnostic, safety, and pharmacokinetic analyses of clinical studies. - Ensure compliance with GCP guidelines and regulatory requirements. - Lead GCP inspection readiness activities, including preparation, hosting, and responding to regulatory findings. - Exercise decision-making authority on clinical quality issues, including addressing GCP breaches. - Develop and review SOPs related to Clinical Quality Assurance, ensuring alignment with GCP and regulations. - Collaborate with cross-functional teams to ensure GCP compliance and provide training on GCP and QA practices. - Identify areas for process improvement and implement corrective and preventive actions (CAPAs). - Leverage extensive experience with US and European companies to navigate different regulatory environments and facilitate global trials. Qualifications - Master’s or bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related fields; advanced degrees preferred. - At least 15+ years of experience in clinical research QA or related areas. - Deep knowledge of GCP guidelines and regulations. - Proven experience conducting GCP audits and inspections. - Strong analytical, problem-solving, and communication skills. - Ability to work independently and collaboratively. - GCP certification is a plus. - Experience working with US and European companies. Benefits USD 4,500/month (CLT) plus all major benefits. Additional Details - Seniority Level: Mid-Senior level - Employment Type: Contract - Job Function: Healthcare Provider - Industries: Human Resources Services #J-18808-Ljbffr