Clinical QA Specialist II – Clinical Specialist Providers

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and maintain the qualification and requalification programs for Clinical Service Providers (CSPs).

• Execute qualification and requalification tasks for Clinical Research Organizations (CROs), laboratories, imaging services, ethics committees, computer systems/software, and other CSPs.

• Identify and address risks associated with clinical service providers.

• Provide oversight for Clinical Quality Assurance (CQA), including managing quality incidents, non-compliances, Corrective and Preventive Actions (CAPAs), serious breaches, and requests for corrective actions from CSPs.

• Negotiate agreements related to quality.

• Act as the CQA representative during study management team and CSP meetings.

• Uphold the core values, policies, procedures, and business ethics of Iovance Biotherapeutics.

• Carry out additional duties as required.

⛳️ Requirements

• Bachelor’s degree in life sciences or an equivalent level of experience.

• More than 5 years of overall experience in Good Clinical Practice (GCP) or Quality Assurance (QA), including at least 2 years focused on oversight of service providers.

• Experience in the qualification and oversight of clinical service providers within pharmaceutical and/or biotechnology sectors.

• Excellent interpersonal, written, and verbal communication skills.

• Outstanding organizational abilities and critical thinking skills.

• Capacity to foster partnerships and diplomatically collaborate with other departments.

• Proficiency in relevant computer software, including Microsoft Office.

• Capability to remain stationary, either standing or sitting, for extended periods.

• Ability to navigate within an office environment and exert up to 10 pounds of force occasionally or negligible force frequently or consistently.

• Visual acuity for data preparation and analysis, viewing computer screens, and extensive reading tasks.

• Skill in performing repetitive wrist, hand, and/or finger movements.

• Ability to communicate effectively with others for information exchange.

• Strong analytical skills, judgment, troubleshooting abilities, administrative capability, critical thinking, task prioritization, problem-solving skills, discretion, stress management, multitasking, and deadline management proficiency.

🏝️ Benefits

• Flexible remote office environment.

• Potential for up to 20% travel.

• Commitment to an equal-opportunity workplace.

• Assistance with application processes and available accommodations.