CSP Oversight Specialist

📋 Description

• Maintain CSP qualification, requalification, and ongoing oversight programs using a structured
• Conduct qualification and requalification activities for a broad range of clinical service
• Identify, assess, and mitigate risks associated with the use and performance of CSPs.
• Provide CQA oversight of service providers and intervene when performance or compliance does not
• Manage quality events, non-compliances, CAPAs, serious breaches, and CSP corrective action requests
• Support the negotiation, implementation, and ongoing management of quality agreements with external

🎯 Requirements

• Bachelor’s degree in life sciences or equivalent professional experience.
• 5+ years of overall experience in GCP, Quality Assurance, or a closely related clinical quality
• At least 2 years of experience specifically focused on clinical service provider oversight.
• Practical knowledge of CSP qualification and requalification, risk assessment, quality events
• Strong written, verbal, and interpersonal communication skills, with the ability to work
• Exceptional organizational, critical-thinking, prioritization, analytical, troubleshooting, and

🎁 Benefits

• Annual base salary range of $110,000–$120,000 USD.
• Remote work environment with standard office equipment and computer-based working arrangements.
• Opportunity to contribute to a global CQA function within a highly regulated clinical development
• Meaningful ownership of CSP qualification, risk management, quality oversight, and compliance
• Cross-functional collaboration with study management teams and external clinical service providers.
• Professional exposure to GCP compliance, clinical quality systems, CAPAs, quality agreements, and