Senior Manager, GCP Compliance will be a critical team member who contributes to implementation of risk-based GCP and compliance oversight. This person will be responsible for the planning, identification, coordination, execution, reporting and closure of CGP Compliance issues in support of clinical programs. The incumbent is also responsible for supporting the GCP auditing plan and assisting its management. Conduct Regulatory Submission Review such as Investigator Brochures (IB), Development Safety Update Report (DSUR), Clinical Study Reports (CSRs), NDAs, Clinical Protocols, ICFs. Conduct/Lead Internal System, process and documentation Audits to ensure compliance to the Code of Federal Regulations, the International Conference of Harmonization (ICH), applicable regulations and company SOPs. Conduct qualification or routine vendor audits of Clinical Research Organizations, Clinical Laboratories, Phase I Units, Imaging Vendors, eTMF Vendors, Investigator Sponsored Trials Assist in the management and closure of GCP CAPAs, including metrics tracking and reporting. Participate in QA Review of Internal SOPs, driving toward establishing and maintaining harmonized and cross-functional SOPs. Perform training and education internally in global GCP standards, and externally as required (Investigator Meetings, CRA Trainings, Pre-Approval Inspections, etc.) Represent GCP QA in assigned weekly protocol project team meetings. Assist with the preparation and hosting activities during regulatory inspections and investigations conducted by various regulatory authorities, including the coordination of timely responses. Support Clinical QA projects. Qualifications Minimum 5 years of increasing experience in a Pharmaceutical/Biotechnology Clinical QA role with at least 3 years of clinical QA auditing and remediation experience. Strong knowledge of global GCP regulations, guidance, and standards. Experience with supporting Health Authority Inspections (FDA, EMA, etc.) Must be able to travel in the US and internationally 20%, or as required based on needs. Excellent collaboration and partnering skills. Ability to work independently and as part of a team. Excellent verbal and written communication skills. Demonstrated ability to effectively organize and execute tasks in a timely manner. Computer proficiency with Word, Excel, and PowerPoint. Experience with an eQMS (Veeva, TrackWise, Master Control, etc.) is a plus Experience working in a clinical operations function is a plus. Experience with the Audit and Review of Safety and Clinical documents is a strong plus Ability to work in a fast-paced, highly collaborative, and dynamic environment.
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