Clinical QA Specialist II, Clinical Specialist Providers (CSP)

Iovance Biotherapeutics seeks a Clinical QA Specialist II to oversee clinical service provider qualification, compliance, and performance. The role involves managing CSP assessments, quality events, risk mitigation, and ensuring GCP compliance across multiple service categories.

Responsibilities

• Maintain CSP qualification and requalification programs using risk-based methodology
• Conduct qualification activities for diverse service providers including CROs, labs, and imaging services
• Identify and mitigate risks associated with CSP operations
• Manage quality events, non-compliances, CAPAs, and negotiate quality agreements
• Represent company at study management team and CSP meetings

Requirements

• BS in life sciences or equivalent professional experience
• 5+ years GCP or QA experience with 2+ years in service provider oversight
• Strong written and oral communication skills
• Exceptional organizational and critical thinking abilities
• Ability to build partnerships and work diplomatically across departments
• Proficiency with MS Office and relevant computer systems