Clinical Quality Assurance Associate II

7 hours ago

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Iovance Biotherapeutics, Inc.

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Immuno Oncology • Autologous Cell Therapy • Tumor Infiltrating Lymphocytes (TIL) • Novel Cancer Immunotherapies • cell therapy

501 - 1000

Description

• Responsible for remotely supporting Iovance’s GCP quality system. • Support GCP quality system activities including clinical quality events, deviations, CAPAs, supplier corrective action requests, investigator site audits, service provider audits, internal audits, clinical change controls and regulatory inspections. • Identify opportunities to increase the efficiency and effectiveness of the GCP QMS. • Support training activities and back-up efforts for clinical quality assurance processes. • Maintain updated knowledge and relevant assessments of the GXP landscape, regulations, and guidelines pertaining to GCP quality assurance. • Some travel required (approximately 10%).

Requirements

• BA/BS or equivalent in life science from an accredited university or college with 2+ years of relevant experience • Current and working knowledge of Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Clinical Practices • Experience with an electronic QMS, MasterControl preferred • Oncology experience is a plus. • Prior experience with regulatory inspections and inspection readiness is a plus. • Must be comfortable in a fast-paced environment with minimal direction and changing priorities. • Strong interpersonal skills and ability to work collaboratively across functions. • Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)