Client is looking for a Senior Clinical QA Consultant for work on Phase 1-3. Primary functions would be to support the VP and provide consulting for quality issues including interpretations and investigations, along with managing a small team (1 perm, 1 pt contractor and the outsourced audit company). Step in as head of GCP, reviewing quality issues/action plans and meeting with staff. Oversee audits ongoing in the US and also globally. Audit work done by an outside company. Review audit reports and provide guidance and interpretations, track findings to resolution and escalate as needed. Additional responsibilities include reviewing quality documents and issues related to CAPA, deviations, investigations, serious breach considerations and other QMS work. All work from clinical perspective phase 1-3. GCP background including patient protections and rights, patient safety and data integrity. Justify what is patient safety issue in the context of a risk based approach. As issues arise this person will do initial interpretation and guidance.
10 plus years of GCP experience with either small or large molecule. Must have some oncology experience and be able to work east coast hours (some off hour meetings for EU and Asia may occur). Experience with inspection readiness is a plus. BS in Scientific area is required.
GCP, QA, Oncology, Audit Review
Start Date: ASAP