Clinical Quality Consultant

Clinical Quality & GCP ComplianceProvide expert-level GCP oversight to ensure clinical trials are planned, executed, and documented in full compliance with ICH‐GCP, study protocols, and internal quality standards.Conduct comprehensive reviews of trial documentation (eTMF, protocols, monitoring reports, site documents) to identify GCP gaps and ensure inspection readiness.Lead and support the management of compliance issues, including identification, escalation, and coordination of corrective/preventive actions (CAPAs).Audit LeadershipServe as a key contributor to the audit program, including trial audits and system audits.Conduct and/or support vendor audits, ensuring CROs, laboratories, and other third parties operate in full compliance with contractual and regulatory requirements.Assist in preparing teams, documents, and systems for regulatory inspections.Cross‐Functional CollaborationWork closely with Quality Assurance, Clinical Operations, and cross‐functional study teams to ensure alignment, quality consistency, and proactive resolution of compliance issues.Partner with external vendors to monitor compliance performance and drive continuous improvement.Experience RequirementsSeveral years of hands‐on experience in GCP, clinical quality, auditing, or clinical compliance roles, preferably within biotech or pharmaceutical environments.Strong knowledge of ICH‐GCP, FDA, EMA, and global regulatory expectations.Demonstrated ability to act as a "heavy hitter"—independent, knowledgeable, and capable of making decisions and driving quality outcomes in a complex clinical environment.