Clinical Compliance Lead – Quality Assurance
Job Description:
• Ensures all clinical operations comply with global regulatory requirements, ICH-GCP guidelines
• Evaluate, revise or create company standard operating procedures (SOPs)
• Act as a key liaison between the Clinical Quality team and cross-functional study teams
• Manage documentation, audits, CAPAs, and vendor qualification processes within the Veeva QMS platform
Requirements:
• Proven expertise creating and managing Clinical QMS
• Auditing expertise and management
• Has held a similar position, Asst. Director level or above
• Expertise in ICH-GCP and E6 R3 guidelines
• Evaluation and Creation of Clinical SOP's
• Vendor qualification experience
• CAPA experience
• Experience acting as a liaison between the Clinical Quality team and cross-functional study teams
Benefits:
• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off
• Remote work options
Apply tot his job
Apply To this Job