Led the Quality function for the DCRI

Provide strategic and tactical consultancy to the DCRI Functional Quality Managers within the Quality By Design organization. Oversees the development, implementation and administration of the DCRI Quality By Design strategy. Serves as an internal expert resource and provides guidance around the design and support of a quality infrastructure. Aligns and improves quality approaches through the use of established quality control gates and assessments. Oversees and executes quality related projects specific to the functions of the DCRI. Leads efforts to develop risk assessments, conduct trend analyses and facilitate process improvement activities

With more than 35 years’ experience at major pharmaceutical, biotechnology and clinical research organizations, I can assist client companies meet and exceed FDA requirements for developing, testing and filing innovative healthcare products. I offer a variety of quality services in the following practice areas:•COMPLIANCE | Quality Systems, cGXPs, Audit Preparedness, Contract Audits, Warning Letters, Consent Decree Remediation•TRIALS | Preclinical and Clinical Quality Design, e-Source, CRO Quality Management, Process Audits•SOFTWARE VALIDATION | Validation Planning, Testing, Documentation, Approaches to AGILE validation, Data Center Audits, Cloud Computing Assessments•TRAINING | Compliance Training, Part 11, Process improvement, Quality System Development•ANALYSIS | Thought Leadership, Systems Based Expertise, Due Diligence, Global Proficiency, Quality Agreements

Part of the SCO leadership team involved in:Process and integrated computer system audits while building quality by design into critical processes. Partner with the business to drive organizational goals and outcomes while remaining in a compliant position.

Knowledgeable quality assurance professional with a focus on cGMP & information technology compliance. Conducted audits and provided consulting services to support DCRI clinical trials.

Firm specializes in SAP implementation, quality compliance design, audits and validation services. •For a major pharmaceutical client created a change request process and organizational structure for a global manufacturing system.•Created a methodology and extensive set of policies/procedures to develop, implement and maintain new and existing global applications supported by Corporate Information Services.•Defined high-level process requirements and mapping for a LIMS implementation in Puerto Rico Quality Control Laboratories.•Led a validation team for a patient management system using ReqPro and Mercury test automation tools

Established an effective audit program across all company locations. The team delivered technical information system audits addressing vendors, third party manufacturers, clinics, research facilities and manufacturing plants worldwide. •Coordinated the redesign of the global regulatory audit function. A revolutionary approach using a multi-functional risk-based profile and scorecard evaluation at key Research, Clinics and Manufacturing sites.•Led a corporate team to harmonize Pfizer’s approach on electronic records and signatures. Worked directly with the FDA and industry groups to influence the direction of these regulations.•Validated Pilgrim’s SmartAudit to streamline the audit function by managing global audit schedules, recording assessment requirements, checklists and effective integration of corrective actions.

Built a skilled QA organization addressing compliance concerns across Pharmacia. Established a multi-phased corporate strategy and policies addressing c-GMP’s, 21CFR Part 11, local and regional regulations. •Created a QA program office for legacy remediation. Built effective communication and training plans.•Devised policies, guidelines and harmonized standards assuring a consistent global approach to application validation, systems infrastructure and workstation quality worldwide

Held a variety of QA roles including Manager of the Sterile Products Laboratory; Sample Processing Center; USP Compendia program; and internal QA audit group. Involved in a new QC Laboratory design in Tskuba Japan, ISO 9001 certification and implementation of a global LIMS approach.