Proactively provide GCP QA support for clinical development activities to protect patient safety & wellbeing, maintain data integrity, and support operational excellence
Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files), internal Process Audits and support Vendor/System audits
Author and manage Audit Plans and Audit reports
Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
Manage health authority inspection preparation activities and provide leadership and oversight during inspections
Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)
Compile and analyze audit metrics to communicate trends to business groups
Maintains a high level of expertise in GCP drug development regulations, ICH guidelines and internal policies and procedures that may impact drug development.
Conduct GCP training sessions for business groups
Build out the GCP function to support pivotal readiness
Manage direct reports (if applicable)

Bachelor’s degree in science-related discipline; advanced degree preferred
Preferably 15+ years’ experience in Clinical research/operations/data management or related area
Minimum of 8 years of Clinical Quality Assurance auditing
Direct/lead experience with FDA, EMA, MHRA, PMDA, or other health authority inspections of sponsor, investigator site(s), and/or CRO(s)
Fundamental knowledge of US, EU and APAC international regulatory standards and guidelines for the conduct of clinical trials
Strong analytical skills and report writing skills
Self-motivated with ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines
Excellent teamwork skills with the ability to develop and maintain positive, collaborative relationships with colleagues at all levels across the organization.
Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
Experience with supervising direct reports preferred

Senior Director, Head of GCP Quality Assurance

Key skills