Provide global GXP leadership, design, operation and quality oversight.

Support process owners and subject matter expertise while maintaining, sustaining and continuously improving standards and processes across the Enterprise in compliance with J&J and external requirements. • Responsible for the development and implementation of processes and procedures to support Enterprise QA system business process while continuously improving and maintaining standards in compliance with regulations and consistent with industry trends.• Interpretation of standards, and proactively monitoring internal and external audit observations and industry trends. • Ensure alignment with J&J Quality Standards and the holistic approach to Quality systems (Organization, Governance, Process, Procedure, People, Electronic System and Measurements) are in place.• Liaison with Enterprise, Segment, and Business process owners to evaluate needs based on applicable standard and process and ensure findings from audits and inspections are incorporated into requirements.

Management of all commercial quality activities related to Taiho’s oral chemotherapy drug Lonsurf®. • Successfully led the serialization of Lonsurf delivering the project 11 months ahead of the FDA deadline. • Led and managed all of the pre-launch and post-launch quality activities resulting in a successful expansion of Lonsurf into Canada.• Management of all quality aspects related to commercial manufacturers/vendors.• Manage and leaned the commercial product quality complaint system resulting in cycle time reduction.• Develop and lead the Quality Management Review to senior management. • Annual Product Review development and presentation to senior management. • Collaborated with Clinical Supplies Department to lean the investigational medicinal product complaint program resulting in a 70% reduction in cycle time for complaint processing. • US QA lead on Matrix and Global Teams (CMC, Quality, SOPs, Trackwise).

Oversee, and coordinate the pre-launch and post-launch commercial quality assurance functions for Lonsurf / TAS-102 (oral anti-tumor agent)• Policy development and compliance assessment of Taiho marketing, sales, medical affairs, manufacturing and distribution activities according to the regulations, guidelines and operating procedures• Vendor Management and Quality Support for pre-launch and post-launch commercial products.

Provide Vendor Management and Quality Support (Audits, CAPAs, Escalations, Complaints, Investigations, Quality Agreements, Batch Release, Quality Documents, and Training) for the North America External Supply Integration – Quality group of the Janssen Supply Chain Group.Quality Project Lead Responsible for Quality Management of a Strategic Packaging Supplier• Collaborated with domestic and international teams to perform value stream mapping of Janssen products resulting in improved cycle time and process flows.• Primary contact responsible for building and maintaining vendor relationship and product quality. Communication with internal and external senior management. • Team member responsible for helping to deliver successful new product launches. Quality Representative for a 4 billion dollar sterile biologic drug product program• Improved cold chain management process resulting in improved cycle time and quality oversight.• Worked successfully to resolve quality issues ensuring supply chain management.• Team member for component changes and process improvement projects.

Provide quality support (Audits, CAPAs, Complaints, Quality Documents, and Training) for the External Supply Integration – Quality (ESI-Q) group of the Janssen Supply Chain Group located in Raritan, New Jersey and Horsham, Pennsylvania.• External Manufacturer (Vendor) Quality Management – review and execution of quality agreements, review and approval of CAPAs, investigations, audits, batch records, specifications, deviation reports, change controls, release of product, etc. • Responsible for auditing external manufacturing and packaging vendors for compliance to Janssen External Supplier Integration quality standards as well current standards (ISO, FDA, etc.) thus ensuring quality service for Janssen products.• Support the ESI-Q complaint system by assigning, reviewing and approving compliant investigations.• Review and approve batch release of product to the supply chain. Results achieved through collaboration, partnership and interfacing with internal partners (Operations, Planning, etc.) as well as external manufacturing and packaging vendors / suppliers.

Provide quality support (Audits, CAPAs, Investigations, Quality Documents, Training) for the ATRM franchise located in Somerville, New Jersey and Raynham, Massachusetts.Quality Representative for a sterile biologic product (Intradiscal rhGDF-5) program: • Collaborate with J&J companies on the manufacturing and quality aspects of the global clinical program. • Partner with Clinical, Regulatory, Supply Chain, Quality Control and Process Development departments on a weekly basis to support the program and help drive the successful progress of the project. • External Manufacturer (Vendor) Quality Management (domestic and international) – review and execution of quality agreements, review and approval of CAPAs, investigations, audits, batch records, specifications, deviation reports, change controls, release of product, etc. • Quality representative on the CMC team.• Conduct internal audits of departments/groups in Raynham and Somerville facilities for compliance to standards, ensuring audit readiness while eliminating the risk of non-compliance.Quality support and oversight for the QC group in Raynham and the Somerville facility • Responsible for auditing vendors, CROs and external manufacturers for compliance to ATRM quality standards as well current standards (ISO, FDA, etc.) thus ensuring quality service for ATRM projects.

Provide quality support for the OCD and Therakos franchises located in Raritan, NJ. • Performed Master Batch Record review and release of OCD products • Review of raw material and in-process testing results performed by the QC laboratory for release and use in manufacturing. • Conducted laboratory investigation and drove CAPAs to closure prior to deadline.• Spreadsheet validationTherakos QA Support 2009 to 2010Responsibility expanded to support Therakos (a division of OCD) a pioneer in immune cell therapy.• Responsible for the quality management of the external vendors used for raw material testing as well as the manufacturing and testing of the drug substance and drug product. • Coordinated activities with the external contract laboratory and API manufacturer • Managed and improved the system for control, storage and inventory of the Active Pharmaceutical Ingredient.• Managed the raw material and finish product stability program. Quality Assurance Auditor 2009 to 2010Responsibility expanded to included participation in the Compliance Department Auditing Team.• Audited vendors and suppliers • Provided quality support in the OCD audit backroom during external agency (FDA, TUV, etc.) audits. LIMS Administrator for the Raritan Facility/SME 2005 to 2010 • Managed the successful deployment of the LIMS the QC laboratory, achieving complete electronic and paperless processes in alignment with the 21CFR Part 11 • Project leader for the successful version upgrade of the LIMS software• Responsible for all aspect of the IQ, OQ and PQ of the software upgradeMetrologist and Test Method Validation 2001 to 2010 Managed and performed all metrology requirements for QA Chemistry lab.• Performed instrument training for technicians.• Reduced the operating cost and improved laboratory efficiency by performing instrument and equipment qualifications (IQ/OQ/PQ), validations, calibrations and repairs in-house.

Managed all aspects of a 24 hour, six day per week, four shift operation responsible for quantitative and qualitative analysis in support of production for this subsidiary of the international, billion dollar conglomerate Carter-Wallace, Inc. located in Cranbury, New Jersey • Supervised, reviewed and approved all aspects of the testing of in-process and finished product material (testing included: active ingredient, description, fragrance, flavor as well as other physical and chemical properties).• Responsible for the quality review of Carter products manufactured at contract manufacturers (batch records, testing results, certificates of analysis, investigations, deviations, CAPAs, etc.). • Identified quality issues with contract manufacturers resulting in new vendors being contracted and vendor investigation and CAPAs reduced.• Supervised, reviewed and approved all aspects of consumer complaint testing (testing included: active ingredient, description, fragrance, flavor as well as other physical and chemical properties). • Applied statistical analysis to reduce unnecessary testing thus increasing the efficiency of the lab.• Converted from laboratory notebooks to computer worksheets for daily testing, resulting in a reduction of transcription and calculation errors while improving efficiency.Carter Second Shift In-Process Quality Control Supervisor and Quality Assurance Line Supervisor 1995 to 1998Supervision expanded (4 direct reports) to include the second shift Quality Assurance Production Line Inspectors. Responsible for all quality attributes pertaining to the packaging of product for distribution.Carter Second Shift In-Process Quality Control Laboratory Supervisor 1994 to 1995Direct supervision of two technicians (second and third shift) for the release of QC laboratory operations, responsible for quantitative and qualitative analysis in support of production and packaging.

Research & Development Technologist/ChemistProvided technical analysis in support of product development for this subsidiary of the international, multibillion dollar conglomerate Mars, Inc., located in Hackettstown, New Jersey. • Supervised cooperative work/education program students in product development testing. • Developed and maintained the Lab Safety Course• Developed new procedures for moisture and humidity analysis resulting in improved accuracy and reduced testing time.• Team member of a successful project to create a heat stable chocolate bar for Desert Storm which resulted in the military contract being awarded to M&M/Mars over competition. • Pesticide Analysis: responsible for the clearance of raw material for commercial purchasing. Upgraded existing system insuring positive confirmation of compounds while reducing analysis time and increasing throughput by 40%.• Sensory Panel member - participated in daily panel for flavor and fragrance testing of finished and raw materials to ensuring that the quality of the product to the consumer is maintained.