Steve Kehoe

Senior Contractor, GxPAssure

Steve Kehoe is a highly experienced pharmaceutical and cGMP consultant with over 16 years’ experience supporting global pharmaceutical manufacturers and extensive expertise in Quality Systems, regulatory compliance, inspection readiness, and Quality Control laboratory operations. He brings more than nine years’ experience as a US Food and Drug Administration (FDA) Investigator, including significant involvement in domestic and international pharmaceutical inspections, having conducted more than 235 FDA inspections, including approximately 85 international pharmaceutical inspections as a member of the FDA Dedicated Foreign Drug Cadre, and has worked across a wide range of dosage forms, API manufacturing, sterile and non-sterile products, biologics, biosimilars, and OTC drug manufacturing environments.

Steve holds a Master of Science in Chemistry from the University of Wisconsin-Madison, and has completed extensive FDA professional training in drug law, evidence development, investigation procedures, process validation, industrial sterilisation, pre-approval inspections, API manufacturing, pharmaceutical investigator training, and FDA Level 1 Investigator Certification. His consultancy experience includes GMP remediation, Quality System design, laboratory and analytical data review, batch record certification, investigation assessment, CAPA, change control, SOP development, equipment qualification, method validation, and preparation for FDA inspections and pre-approval inspections. He has supported global pharmaceutical, API, sterile, biosimilar, OTC, and generic manufacturers with compliance improvement, regulatory response, Quality Unit assessment, and sustainable GMP operations, including FDA commitments following Warning Letters and inspection observations, Quality Risk Management aligned with ICH Q9, and Pharmaceutical Quality Systems aligned with ICH Q10.

• Quality Systems design, implementation, assessment, remediation, and continuous improvement for pharmaceutical manufacturers.
• Selected to serve in the FDA Dedicated Foreign Drug Cadre, performing high-risk inspections of pharmaceutical manufacturers across Europe, Asia, Africa, the Middle East, and North America.
• FDA inspection readiness, pre-approval inspection preparation, FDA 483 response support, warning letter remediation, and regulatory compliance strategy.
• Assessment, review, and approval of quality investigations, including OOS, OOT, deviation, complaint, CAPA, and change control processes.
• Batch record review, analytical data review, batch certification, and evaluation of GMP documentation for sterile, non-sterile, API, OTC, biosimilar, and finished pharmaceutical products.
• Application of FDA’s six-system inspection model: Quality Systems, Production, Facilities & Equipment, Laboratory Controls, Materials Management, and Packaging & Labelling.
• Analytical method validation, method verification, cleaning validation, raw material qualification, product specifications, and review of chromatographic and analytical techniques including HPLC, GC, FT-IR, NIR, UV, AA, PSD, TOC, and Karl Fischer water content analysis.
• Audit leadership and execution using FDA inspection principles, including quality management system audits, laboratory assessments, and constructive compliance feedback to site teams.
• Development and revision of SOPs, policies, protocols, quality documentation, training materials, and GMP procedures.
• Project management of complex compliance remediation programs for international pharmaceutical manufacturers across Europe, Asia, Africa, the Middle East, as well as North America.
• Multi-site Quality Culture assessments, across the US, Europe, and India.
• Representative consulting support for multinational and specialist pharmaceutical organisations including Genentech/Roche, Teva Pharmaceuticals, Natco, Shilpa Medicare, Akorn Pharmaceuticals, Curia, Dyno Manufacturing, and Avantor, subject to client confidentiality and public-use approval.
• Strong technical communication, inspection report writing, stakeholder engagement, and collaboration with senior management, Quality Units, regulatory personnel, and multidisciplinary project teams.
• Preparation of Establishment Inspection Reports (EIRs), regulatory evidence packages, and regulatory action recommendations involving significant cGMP and data integrity concerns.