GCP Quality Assurance Candidate

This position will be responsible for GCP/Clinical Quality Assurance activities. The primary responsibilities will be to ensure to quality and compliance of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Madrigal SOPs, and current industry standards and best practices. This position reports into the Senior Director, GCP Quality. Responsibilities: Ensure clinical trial activities are compliant with ICH and applicable country regulations and guidelines and industry standards Align organization to ICH in implementing a quality culture from the outset of clinical trials to promote patient safety and data integrity Apply a risk-based approach by working collaboratively cross-functionally to ensure compliance Attend routine internal, external study team and ad hoc calls in support of ongoing quality oversight Engage partnership with external vendors via adherence to Quality Agreements and routine meetings Coordinate reviews, management documentation, track and/or follow-up on internal Quality Event investigations, deviations, Observations/Findings, CAPAs, etc. to ensure closure Support the use of an eQMS via data entry/document upload of quality activities (audits, observations, inspections, CAPAs, SOP Deviations, QEs/Investigations) and SOP updates Contribute to the annual audit plan Assure through Qualification audits and oversight activities that clinical trial vendors are operating in compliance with all applicable procedures, study documents, regulations/guidelines May review vendor MSA or contract/Work Orders Conduct or manage internal/external audits (vendor, site, document, system or process) and prepare or review audit reports Coordinate and manage services provided by external QA vendors Review key documents, such as IB, Protocols/Amendments, Consents, TMF Plans Inform and escalate to management in real-time or during routine updates, as appropriate Participate in inspection readiness activities or provide support during global agency inspections Conduct other tasks in support of GCP Quality activities, (e.g., chase training assignments, request contracts) Stay abreast of applicable global regulations, guidances, and industry best practices Qualifications: Overall qualification by experience to support the responsibilities not limited to those outlined above Demonstrated GCP knowledge, GLP/GVP knowledge a plus Solid understanding of the cross-functional drug development process including specific to clinical trial operations, data management, statistics, etc Skilled in developing collaborative internal and external relationships Business and Operational acumen to include escalation to management Ability to interact with all levels within an organization Experience in inspection preparation or supporting regulatory agency inspections Experience in using eQMS systems, such as Veeva BS in a scientific or other relevant discipline with equivalent work experience