Design and implement robust and effective phase-appropriate quality systems for client organizations, including virtual startups and large corporations. Develop custom content for training to client organization partners, including production operators, laboratory analysts, managers, and senior leadership. Administer comprehensive QA support for clients on multiple concurrent projects involving numerous Contract Development and/or Manufacturing Organizations (CDMOs) in North America, Oceania, and Europe. Projects encompass product development, scale-up, technology transfer, and commercialization of drug products and drug substances, including DEA controlled substances. • Prepared overseas facility for success in first FDA pre-approval inspection, through a thorough review of manufacturing processes and production operations, identification of compliance gaps, and prioritization and implementation of robust “fixes” (training, procedure writing and revision, review of data, compilation of documentation) and preparing front-line personnel for interactions with FDA personnel.• Provided QA leadership on five projects culminating in FDA approvals. • Conducted due diligence audits of prospective contract partners and continued to monitor third-party operations (e.g., periodic GMP compliance auditing, onsite oversight of critical processes) • Negotiated Technical and Quality Agreements with contractor Quality management.• Administered Change Control programs, managed investigations (e.g., Out of Specification (OOS), OOT (Out of Trend), deviations) and CAPA implementation.• Approved and controlled GMP records and reports (e.g., master & batch production and control; process validation, analytical validation, and stability).• Compiled Annual Product Review (APR) reports and Minor Changes and Stability Report (MCSR) content; audited Chemistry, Manufacturing and Controls dossiers.

Merial Limited (now Boehringer Ingelheim Animal Health). Provided QA leadership and surveillance during the transfer of several long-established drug product formulations to a new, 100,000 square foot manufacturing site in New Zealand. Supported and monitored the commercial manufacture of several Active Pharmaceutical Ingredients (APIs), and oral, topical, and sterile injectable drug products. Appraised and certified Contract Manufacturing Organizations (CMOs). Administered the Change Control system (including Global impact). Managed the Product Quality Complaints program. Reviewed Annual Product Review reports and monitored implementation of any CAPA. Hired, guided, and motivated professional staff.• Restructured an internal site’s Quality System following discovery of GMP non-compliance; replaced site Quality Manager; conducted widespread gap analysis and implemented or revised procedures; conducted extensive training; returned facility to full and continued compliance with FDA regulations;• Instituted North America Quality System for Third-Party Contract Manufacturing after Merck, Merial’s parent company at that time, discontinued manufacture of products in Merial’s portfolio. • Negotiated Quality Agreements with third party manufacturing partners to ensure that roles and responsibilities were clearly defined, and in alignment with the company’s business requirements. • Monitored CMO performance and facilitated investigation of product quality issues in collaboration with internal stakeholders (e.g., Development, Supply Chain).