• support the Good Clinical Practice (GCP) Quality Assurance (QA) function • perform day-to-day GCP QA operations • execute and/or ensure proper oversight of GCP QA activities • perform external and internal audits • support clinical phase 1 to phase 4 study team activities • review documents • support regulatory inspections • enhance GCP QA infrastructure development • manage or perform clinical site, internal, TMF, GCP, and GLP vendor audits • generate and/or review GCP and GLP QA audit plans and schedules • generate and/or review and approve audit trend reports across programs • communicate, address, and prevent identified GCP compliance issues and trends • develop and manage audit programs • represent QA at program-wide meetings • serve as point of escalation for GCP compliance issues • embed Quality ‑ by ‑ Design (QbD) and Critical ‑ to ‑ Quality (CtQ) principles into study planning and execution • investigate, manage, and track GCP CAPAs, deviations, and other quality issues • collaborate with cross-functional teams • assist with serious breach assessments and notifications • provide guidance and support to Trial Master File activities • review study-specific documents • partner with cross-functional groups and promote compliance • attend governance meetings • identify and address quality systems gaps • author, review, or revise SOPs, Work Instructions, Policies, and Job Aids • deliver training to internal and external stakeholders • support regulatory inspections and inspection readiness activities • prepare clinical sites for inspection readiness • draft and recommend Quality Agreements for GCP/GLP vendors • direct/supervise personnel; including coaching, mentoring, development, and performance management