Quality consulting expertise for life science companies supporting critical quality systems implementations, harmonization and improvement, and GxP inspection readiness.
Focus on areas of GxP Quality Assurance, Quality Operations, GxP gap analysis and remediation strategy development, Computerized Systems Validation, Computerized Systems Assurance program implementation, and Data Integrity Program implementation.

Developed and oversaw all of the company's Quality Assurance organization (Quality Operations, QC, R&D QA, IT QA, Quality Management Systems, Quality Engineering, Clinical Quality Assurance, Supplier Quality). Responsible for ensuring quality assurance requirements are met across all of the company's business segments of Medical Device, Biologics, and Tissue. (ISO, CFR, AATB).
Reason for leaving: Supporting 2 immediate family members diagnosed with terminal illnesses in 2021.

Quality oversight of tobacco GMP manufacture at 9 sites, ISO at 38 FMCG sites, GLP and GCP at all relevant sites across US, ASIA and EU).
Accelerate the Company's Life Science/Device (Reduced Risk Products/RRPs) Division QMS, organization, and capabilities to be FDA, Swissmedic, and EU inspection-ready by end of 2017. Ensured all GxP inspections were successful with FDA across PMI's sites in Italy, Switzerland, Malaysia, Singapore, and the USA (including 2 GCP site inspections).

Senior Quality Consultant/Partner in Europe, providing quality oversight, lead auditing, consulting and collaboration for clients related to global quality and compliance, including, but not limited to ISO and cGXP compliance assurance.

Executive Leadership team member within the Company’s H&N Global Quality Organization (Direct reports: 15 Quality Operations Managers/Sites internationally). Responsible for all of FMC Quality Systems, Quality Operations, IT Quality, and Quality Control Teams. Hands on approach to harmonizing quality best practices across all sites in an international landscape.
INCREASED CONSULTING WORK WITH NSF IN EUROPE – REMAINED IN EUROPE TO CARE FOR FATHER

Achieved Corporate Recognition Awards for:
o Computerized Systems Validation Remediation Program
o Leading Investigation and Improvement implementation for a complex, business-critical supplier quality issue
Provided Quality Operations leadership, development and oversight for teams supporting Quality Operations, Quality Systems, Quality Engineering, Regulatory Audit, Investigation, Complaint Handling and Operational Excellence, Supplier Quality.

 Oversaw the company’s Global Quality Organization for US, EU and ASIA/PAC
 Oversaw development of key client proposals and budgets for Big 5 Pharma clients
 Ensured the company’s Quality Management System (QMS) and Quality Policies across multiple departments and global offices are in compliance to applicable standards related to life sciences and other regulated industries
RETURNED TO THE US EAST COAST TO CARE FOR IMMEDIATE FAMILY MEMBER

Recognition awards for joint collaboration between Novartis and Eli Lilly related to marketing authorizations in Europe for large and small molecule projects
Oversight of multiple Contract Manufacturers (Drug substance, drug product), Contract Testing Labs, and Third-Party Logistics
Responsible for Company's Computerized Systems Validation Program.
Implemented Company-Wide Electronic QMS.

Executive team member with oversight of the company’s Quality Assurance and Regulatory Affairs Groups
Managed Quality Operations staff responsible for general and sterile compounding (USC 503a and 503b)
Responsible for hosting Federal and State health authority inspections
Oversight of compounding of small-batch clinical supplies for industry and academia