Lead Quality Control (QC) activities to support the manufacture of Human Cell, Tissues, and Cellular Tissue-Based Products (HCT/P’s). QC activities include product testing, equipment management program, sterility assurance, environmental monitoring testing of cleanrooms/personnel, facilities maintenance support. Develop, review, approve validation documents.

Conduct compliance functions including internal auditing, regulatory registrations and submissions, and supplier management program.

Initiated and developed Quality Management System for devices in compliance with FDA regulations and ISO 14385 standard. Audited contract manufacturer of medical devices as part of supplier qualification.

Oversaw a wide variety of validations to support production in the regenerative medicine space. Maintained compliance with EU and FDA cGMP, American Association of Blood Banks (AABB), and American Association of Tissue Banks (AATB) regulations and standards. Performed FMEA. Supervised staff in a wide range of validation projects for equipment, facility qualification, packaging, assay method, and aseptic process.

Managed external client audits. Maintained compliance for biological products within the scope of EU and FDA cGMP, CLIA, AAB and PPTA regulations and standards. Led cross-functional teams for external audits and corporate inspections. Developed site master file for preparation of regulatory audits.

Provided oversight in making quality and product safety evaluations for the manufacturing of parenteral drug products. Developed and maintained the pharmaceutical quality system in compliance with FDA and EU cGMP. Reviewed and approved validation documentation for facility commissioning and qualification . Reviewed and approved QC testing of product for use in investigative clinical trials.

Maintained quality system for manufacture of medical devices in compliance with FDA regulations and ISO 14385 standard. Maintained state-level licensure and AATB accreditation documents for FDA registered tissue bank. Processed complaints and presented data to executive management. Updated technical files and design dossiers to support Notified Body audit.

Managed analytical laboratory to support product development and production operations. Performed analytical (QC) testing and outsourced testing to contract labs in support of a successful IND submission for phase 1 clinical trial. Created cGMP compliant system for reporting, reviewing, and releasing QC data for Phase 1 clinical trial.

Supervised team in development and validation of assays for product release and stability testing; communicated timelines, scheduled and oversaw execution of milestones. Developed and validated QC test methods. Trained QC analysts on routine performance of testing. Investigated out of specification results and performed troubleshooting on equipment and challenging methods.