Clinical Quality Assurance Manager

Direct Biologics is a market leading innovator and science-based cGMP manufacturer of regenerative biologic products. We are currently looking for a Clinical Quality Assurance Manager.

General CQA Responsibilities:

• Create risk-based Quality Audit Plans for each clinical trial study / program and ensure they are implemented and executed.
• Perform Vendor, Investigator Site, PV, and document audits.  Manage the risk management for planning GCP audits.

• Perform final site regulatory approval and release of IMP.
• Occasional quality control review of packaging and shipping activities which includes approving records.
• Supports VP of Quality with tasks related to product quality including but not limited to IMP temperature excursions, document reviews/approvals, and risk assessments.

• Assist Regulatory Affairs by providing content for Safety reports, Annual Reports, INDs, BLA’s,...