Das ist der Job
Proficient in implementing quality metrics frameworks and optimizing eQMS workflows for global clinical programs.
Darum lohnt es sich
Responsibilities
• Leads GCP quality oversight for global clinical program(s) to ensure sustained compliance, inspection readiness across internal teams.
• Implements standards for risk-based oversight, issue management rigor, translating quality signals into cross-functional actions that protect participants and data integrity.
• Oversees quality performance across a portfolio of programs and studies, ensuring measurable recurrence reduction.
• Provides executive-ready reporting on quality risks, trends, and readiness.
• May lead/mentor GCP quality staff.
Requirements
• Minimum 10 years in clinical quality assurance
• Minimum 3 years experience in a clinical operations role at a CRO or Sponsor
• Demonstrated experience conducting and/or overseeing vendor, investigator site, Document/TMF, and process audits.
• BS+ in Life Sciences or related discipline (Preferred)
• Experience leading global health authority inspection readiness and responses (e.g., FDA) across sponsor‑led and outsourced models (Preferred)
• Experience implementing/optimizing eQMS workflows and quality metrics frameworks for GCP oversight at scale; Veeva Quality a plus (Preferred)
Core Competencies
Demonstrates extensive expertise in GCP quality oversight, ensuring compliance and inspection readiness while leading cross‑functional actions to protect participant safety and data integrity.
