Teams at Precision For Medicine

Lead and execute GCP process audits, internal and vendor assessments, investigator site and TMF audits; support QA systems (SOPs, CAPA, training), computer systems validation, sponsor/client audits, regulatory inspections, and provide QA consultation to project teams to ensure compliance with GCP/ICH and FDA.

Lead and execute GCP process audits and quality oversight across clinical studies. Maintain QMS (SOPs, training, CAPA), manage vendor/site/TMF/internal audits, support regulatory inspections, participate in computer system validation and change control, provide QA consultation to project teams, and monitor quality metrics and corrective actions to ensure compliance with GCP/ICH and FDA regulations.

Lead and execute GCP process, vendor, site, and TMF audits; support QMS (SOPs, training, CAPA), host sponsor audits and inspections, advise project teams on QA, manage quality issues/CAPAs, maintain trackers/metrics, and support validation of clinical systems to ensure regulatory compliance.