Expert in Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
He has designed quality system for a US virtual pharmaceutical manufacturer to enable the firm introduce its products, manufactured in Asia, into the US marketplace. He has implemented SOPs, Quality and Supply Agreements and GMP Training programs for clients.He has conducted several audits of API and finished products manufacturers for clients. He has also helped clients select vendors. He has conducted audits in the United States, India, China, and Europe.He was a member of a client's Due Diligence team that evaluated acquisition targets. Provided QA/QC input to the team, including risk assessment.He has conducted a gap analysis of a client's Quality System, put together a Remediation Plan and guided the implementation of the plan.He is currently leading a team of experts that is conducting a feasibility study of building a Sterile Manufacturing plant in Nigeria.
Expert may consult nationally and internationally, and is also local to the following cities: Los Angeles, California - San Diego, California - Long Beach, California - Santa Ana, California - Anaheim, California - Riverside, California - Glendale, California - Huntington Beach, California - San Bernardino, California - Chula Vista, California
|Year: 1988||Degree: PhD||Subject: Industrial Pharmacy||Institution: St. John's University, New York|
|Year: 1984||Degree: MS||Subject: Industrial Pharmacy||Institution: St. John's University, New York|
|Year: 1979||Degree: BS||Subject: Chemistry||Institution: University of Ibadan, Nigeria|
|Years: 2007 to 2011||Employer: OnyexxPharma LLC||Title: CEO||Department:||Responsibilities: He is an independent compliance consultant specializing in pharmaceutical, biopharmaceutical, and medical device GMP-compliance issues. He guides pharmaceutical and allied product manufacturers in the U.S. and Asia in the introduction of new products and technologies in the U.S., Africa, and other emerging economies.
|Years: 2005 to 2007||Employer: Spectrum Pharmaceuticals Inc.||Title: Vice President, Global Quality Operations||Department: QA/QC||Responsibilities: He was responsible for quality assurance / quality control initiatives in support of global drug development, clinical supplies manufacturing, commercial drug manufacturing, pre-approval inspections for new product introductions, and due-diligence efforts for in-and out-licensing activities. He implemented systems that assured laboratory and study sites in the U.S. and Europe were in full compliance.
|Years: 2003 to 2005||Employer: Purdue Pharma LP||Title: Executive Director||Department: External Manufacturing & Supplier Quality||Responsibilities: He spearheaded quality and risk-management activities pivotal for the successful launch of multimillion-dollar products sourced from third-party manufacturers and packagers. He implemented supplier auditing and qualification programs and quality and supply agreements. He provided quality directions for potential acquisition targets.|
|Years: 2001 to 2003||Employer: Purdue Pharma LP||Title: Executive Director||Department: Manufacturing Quality||Responsibilities: He led quality control and quality assurance activities for all plant operations for a $2,000,000,000.00, three-plant operation. He acted as company liaison during FDA Inspections and led the development of responses to inspection observations and implementation of corrective / preventive-action plans.|
|Years: 1997 to 2001||Employer: Ortho-McNeil Pharmaceuticals (J&J)||Title: Site Director, QA/QC||Department: Quality||Responsibilities: He managed a staff of over 90 responsible for manufacturing quality and compliance development and oversight for two plants representing over $2,000,000,000 in annual sales. Provided leadership in designing and implementing "Lean Lab" at the Raritan site.
|Years: 1994 to 1997||Employer: Hoffmann-La Roche Inc., New Jersey||Title: Group Leader, Analytics||Department: Quality Management||Responsibilities: He led 40 scientists engaged in analytical R&D, troubleshooting of Operations' technical issues, stability testing and management, methods development and optimization and laboratory automation.|
|Years: 1991 to 1994||Employer: Hoffmann-La Roche||Title: Associate Research Investigator||Department: Quality Management||Responsibilities: Led a team of chemists that developed and validated analytical methods, developed and compiled the CMC section of NDAs.|
|Years||Country / Region||Summary|
|Years: 1996 to 1997||Country / Region: Rome||Summary: QA/QC representative on strategic partnership meetings with an Italian pharmaceutical company.|
|Years: 2002 to 2010||Country / Region: India||Summary: Several trips to India on audits of API and Excipient manufacturers. Trips to qualify and select finished products and API manufacturers.|
|Years: 2003 to Present||Country / Region: China||Summary: Trip to audit an API manufacturer and to investigate another for material failure.|
|Years: 2003 to Present||Country / Region: Spain||Summary: Part of a Due Diligence team for an acquisition target.|
|Years: 2007 to Present||Country / Region: Germany and the Netherlands||Summary: Audit of Laboratories for GLP studies. Visit with study partner for follow up audit and close out of previous audit findings and review of CAPA.|
|Associations / Societies|
|AAPS (American Association for Pharmaceutical Scientists); ISPE; PDA|
|Former Editor: Pharmaceutical Quality and Control and Dissolution Technlogies|
|Training / Seminars|
|Provided company-wide training on Good Manufacturing Practices, Good Laboratory Practices, General Regulatory Agency Inspection Readiness. Have provided targeted training on Supplier Qualification and Selection, Development of SOPs and Product Complaint Handling.|
|As Executive Director Supplier Quality, he led the qualification and selection of contract manufacturers and contract testing laboratories for company. Led the development of strategies for selecting contract testing laboratories at Hoffmann-La Roche.
He has helped source, qualify and select API and finished products contract manufacturers for clients. Vendors evaluated were located both within the United States, Europe and Asia.
|Other Relevant Experience|
|He has traveled to developed and emerging economies, including the USA, India, Japan, China, Nigeria, Brazil, Spain and Germany for projects.|