Strategic and operational consulting for the pharma, biotech and medical device industries. Services are in the areas of Quality, Regulatory, Organizational Design, Supply Chain, Manufacturing andProduct Development. Professional coaching, mentoring and serving as interim management

A life science consulting firm focused on strategic, operational, quality/regulatory and technical solutions for biotech and pharmaceutical companies. Head of Quality & Regulatory practice. Responsible for building a new practice including staffing and service offerings. Service offerings include: regulatory landscaping, CMC/CTD authoring, Quality Systems Remediation, Cold Chain Compliance, PAI readiness, Warning Letter Remediation, Transfer Technology, Corporate Quality/Regulatory Organizational Design, Supplier Quality Management

General consulting practice supporting primarily regulated Pharmaceutical, API, Medical Device, In Vitro Diagnostic and Biotech companies. Auditing, Due Diligence, Quality Systems, Quality Improvement Plans, Organization Design & Coaching, Validation, Facility Design, Product Lifecycle Management, Tech Transfer

Established a Corporate Quality organization and the associated quality systems designed to meet the needs of Millipore Corporation’s life science industry customers and in particular the Biotech and Pharmaceutical customers; and to have quality as a competitive advantage. Re-established the company’s quality reputation and customer confidence.• As a corporate officer reporting directly to the CEO, managed the Corporate Quality, Regulatory and Project Management organizations• Transformed corporate culture from a ‘test in quality’ philosophy to a ‘build in quality’ philosophy; revised Product Development Process (PDP) to improve the quality and commercial viability of products • Established standard quality metrics to prioritize quality initiatives as well as to monitor their progress• Integrated the corporate quality strategy into corporate/divisional strategies; served as a conduit for the voice of the customer• Implemented fully validated, Part 11 compliant corporate wide integrated quality systems that were scaleable. Corporate databases implemented included: training, document management, audit management, corrective action/preventative action, complaint management• Established a Corporate Project Management Office as a new corporate expert function• Established a Corporate Quality Engineering function as a center of excellence within quality• Served on Steering Committees for Mergers & Acquisitions• Served as an internal consultant for biotech, diagnostics, pharmaceutical technologies and business practices• Significantly reduced the “cost of quality’ which resulted in $20 M saving/year while improving compliance and quality levels

Established a Divisional Quality Function through recruitment, staff development, leadership and building relationships with other functional groups.For Dura Pharmaceuticals prior to acquistion by Elan: Managed Quality Assurance and Quality Control staff that supported product development of combination pulmonary drug/medical device products and contract manufactured commercial products in various dosage forms. Also served as interim VP Regulatory

Established a Corporate Quality department. • Designed a corporate quality function based on an assessment of Watson’s needs. Recruited and managed corporate quality staff that covered auditing, policy & guidance, quality engineering, technology transfer & validation and training• Developed and managed a comprehensive Quality Improvement Program (QIP) to address prior FDA cited deficiencies as well as to prepare the company for continued growth. • Served as acting QA Director for the Corona site for several months while recruiting for QA Director

Responsible for coordinating all validation activities, worldwide.• Established corporate validation standards• Implemented corporate validation standards by: authoring validation guidelines, providing training, conducting GMP/validation assessments and managing validation projects• Managed corporate validation staff both in the USA and in Europe• Provided guidance for strategic projects• Coordinated Quality due diligence audit teams/reports for merger with HMR

Responsible for corporate quality assurance oversight of international manufacturing plants producing medical devices, pharmaceutical and nutritional product under Wyeth, Ayerst, Whitehall-Robins and Lederle names. • Provided training in: GMP, ISO 9000, validation, statistical process control• Authorized new product introductions through reviews of: master formula, master batch record, validation documents, product labeling and third party testing of validation lots.• Conducted GMP and ISO 9000 audits of manufacturing facilities including contract manufacturers. Facilitated ISO registration of three facilities• Facilitated inter-company and consumer complaint investigation and resolution• Provided design input for new manufacturing facilities• Integrated American Cyanamid/Lederle facilities• Managed multiple sites in: Australia, Korea, India, Pakistan, Hong Kong, Japan, China, South Africa and USA

Contract Quality Assurance Specialist, 1990 – 1992Responsible for the supplier quality management of contract manufacturers and critical raw material suppliers used by Ortho Diagnostics.• Assisted in the development of a formal supplier management program• Performed GMP and process audits• Approved complaint investigations and monitored corrective actions• Monitored supplier quality using statistical process/quality control (Six Sigma)• Served on ISO 9000 Compliance Implementation TeamScientist, 1990Product development of viral diagnostic assays for HIV-1 (AIDS) and Hepatitis C• Characterization of recombinant, synthetic and viral lysate derived proteins• Characterization and development of antibodies for QC panel and assay reagents

Area Immunologist (Manufacturing Technical), 1989 – 1990Provided quality management and technical support for several facilities used for manufacturing diagnostic assays or assay reagents• Trained production and QC staff for BSL-3 facility• Implemented significant improvements that improved yields and product quality. Validated viral lysate production process• Managed QC staff• Coordinated production schedule with production planning and marketingArea Immunologist (Method Leader), 1986 – 1989Method leader responsible for product development of diagnostic assays for Hepatitis B and several cancer markers• Developed Hepatitis B diagnostic: scaled-up, completed IND and transferred product to manufacturing• Managed several research techniciansMicrobiologist, 1985 – 1986Product development of diagnostic assays• Provided critical expertise as part of the team responsible for the successful troubleshooting and commercialization of one of the first HIV blood diagnostic assays• Co-developed assay for sexually transmitted disease, Trichomonas vaginalis

Managed independent research project of novel anti-cancer and immunomodulatory compounds• Investigated and characterized potential compounds• Determined effect of formulation and dosage form on drug activity/efficacy

Manufacturing technologist for the manufacture of blood banking antisera• Assisted in the design, commissioning and operation of a new antisera production facility• Trained staff and initiated improvements that resulted in a $2 million increase in production