CSP Oversight Specialist

About the role

Our partner is looking for a CSP Oversight Specialist based in United States. This role is an integral part of a global Clinical Quality Assurance (CQA) function, supporting both internal teams and clinical service providers (CSPs). You will help ensure external partners are appropriately qualified, periodically reassessed, and capable of consistently meeting quality and compliance expectations. The position combines risk-based oversight, quality event management, corrective action oversight, and quality agreement activities within a regulated clinical development environment. You will collaborate closely with study teams and service providers while helping maintain GCP compliance across applicable regulations, guidelines, policies, and procedures. The role is well suited to a highly organized and analytical professional who enjoys solving complex problems and building effective cross-functional partnerships. Working in a fast-paced and evolving environment, you will have meaningful ownership over CSP quality and oversight programs.

Responsibilities

• Maintain CSP qualification, requalification, and ongoing oversight programs using a structured, risk-based approach.
• Conduct qualification and requalification activities for a broad range of clinical service providers, including CROs, laboratories, imaging providers, ethics committees, and computer systems or software vendors.
• 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 meet expectations.
• Manage quality events, non-compliances, CAPAs, serious breaches, and CSP corrective action requests (CSPCARs), ensuring appropriate follow-up and resolution.
• Support the negotiation, implementation, and ongoing management of quality agreements with external service providers.
• Represent the quality function in study management team meetings and CSP meetings, providing relevant quality and compliance guidance.
• Apply company policies, procedures, business ethics, and quality standards consistently while taking ownership of assigned responsibilities and additional duties as required.
• Travel periodically to support business and CSP oversight activities, with travel of up to 20%.

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 discipline.
• At least 2 years of experience specifically focused on clinical service provider oversight.
• Practical knowledge of CSP qualification and requalification, risk assessment, quality events, CAPAs, non-compliances, and GCP requirements.
• Strong written, verbal, and interpersonal communication skills, with the ability to work diplomatically and build productive partnerships across departments.
• Exceptional organizational, critical-thinking, prioritization, analytical, troubleshooting, and problem-solving abilities.
• Ability to manage multiple priorities simultaneously, exercise sound judgment and discretion, and consistently meet deadlines in a fast-paced environment.
• Prof