COMPLIANCE, QA, & REGULATORY AFFAIRS
- 13 years in the compliance field.
GXP Auditor, Training, and Document Management; Developing Quality Systems; Part 11 Compliance (back and front end, software and hardware); Validation (process and equipment); Global CMO Oversight and Batch Record Review (France, Italy, Germany); GLP Studies (PK and Tox, rodents/primates); QC of Raw Materials, EM, Utilities, Cleanrooms, Facilities; GCP Site Audits; EDC/RDC Data Verification.
Performed GXP vendor audits and served as Supplier Quality Engineer, International Medical Device manufacturer of CT/MRI systems, FDA remediation team member, and site SCAR manager. QA lead for transgenic product, Phase I to commercial scale, and QA document author/reviewer/approver for QS documents and templates. Provided lab notebook verification and reconciliation. Served as foreign CMO project manager for clinical supply, reviewed and approved in-house QC methods for product release and computerized GCP systems, provided support to clinical operations, and reviewed and approved pre-clinical/development reports. Provided GCP/GMP batch record review, foreign CMO batch record review, GCP labeling on-site at CMO, GLP review of in-house and CRO reports, GCP documentation support, and IND data review. Reviewed and revised quality documents and supported QS document archive.
Corporate QA Team Lead, BLCPro – Clinical Trial Database Center
Team Lead for a company that designed, tested, and managed all aspects of clinical trial databases and data flow for clients, as well as for investigator laptops and patient devices (e-diary), including data migration to new database versions. Designed and implemented GCP corporate quality systems and training, and wrote all supporting documents required for GCP functions. While providing data management services for Pfizer clinical trials, was responsible for internal oversight, with direct customer contact with Pfizer management. Performed internal and external audits.
QA Consultant, QA Solutions
GCP Auditor of Phase 3 vaccine study (autologous cell-mediated response). Wrote quality system documents.
QA Consultant, Vitex Pharmaceuticals – Biotechnology Company
Performed CMO/CRO vendor approval and oversight for Phase 3 blood product (first-in-human). Reviewed QC testing data, and approved and released raw materials and final product. Reviewed batch records. Provided GXP training and documentation support.
Lead Auditor, QA Compliance, Lonza Biologics – Global Viral Therapy/Biologics Manufacturing Company
Responsible for Division’s Vendor Quality Audit program (GCP, GMP, ICH, GLP) in the CRO/CMO cell culture API facility. Reviewed and approved validation data and protocols and oversaw regulatory and sponsor audits (FDA, EMEA, Health Canada, Italy, Japan). Coordinated and generated audit responses and 21CFR Part 11 compliance program. Facilitated materials review board (MRB) and strategic second sourcing for raw materials. Supported QC raw materials and QC testing labs (Biochem, Micro, and EM) for compliance-related issues.
Quality Assurance Manager, UniClean – Cleanroom Services Provider
Managed the daily operations of two ISO 9002-certified cleanroom manufacturing facilities (TUV ISO Registrar). Rewrote Quality Manual and associated SOPs to reflect changes in ISO standards. Performed internal and external audits of all critical areas, processes, and suppliers. Administered all SOPs and employee training. Re-instituted an ANSI-compliant sterilization program. Designed and instituted environmental monitoring program and chaired OSHA safety committee.