Robert M. Dillard Email & Phone Number

Lansdale, Pa, Us

New Brunswick, Nj, Us

• Works cross functionally within multiple segments (Medical Device, Consumer and Pharma) providing strategic leadership for remediation and other compliance driven projects. Assigns projects or activities to individual contributors. Demonstrates excellent written, verbal and presentation skills including experience presenting at meetings with Sr. level management and Regulatory Authorities. Stays aware of industry best practices and works with team members including Global Orthopaedics, DePuy Synthes and various commercial partners to oversee the Regulatory and Quality Assurance aspects of new products launches, the submission of license applications, and the assessment of the impact product changes have on the status of regulatory licenses. Performs Risk Management Analysis, copy material review including brochures, instructions for use (IFUs) and labels. Develops analytics to support data driven decision making. Use of Agile, Widchill, and MS Project.

• Directs and coordinates activities concerned with the submission and approval of products to government regulatory agencies• Provides guidance to project team members regarding regulatory compliance issues• Oversees the preparation and maintenance of regulatory submissions and files• Establishes accountability for the preparation of necessary outputs, including outlines, summaries, status reports, memos, graphs, charts, tables, and slides• Ensures adherence to standard operating procedures and protocols for the rapid and timely approval of new products and regulatory support of marketed products• Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters • Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals

Mumbai, Maharastra, In

• Responsible for oversight of facility Quality Management System (QMS), inclusive of the following programs, CAPA, Change Control, Investigations, Complaints and Annual Product Reviews • When necessary, directs and co-ordinates the activities of subordinate supervisors, and QA employees through the maintenance of valid performance plans to ensure timely manufacture and packaging of products • When necessary, maintains short-term performance goals, training plans, and monitors results to reflect a changing environment • Interacts with Operations to assure statistically based quality systems for use in the quantitative measurement of process variability. Maintain systems to track and trends key quality system indicators. (Metrics and Pareto Charts).• Assures that an effective audit program maintains compliance at the facility • Responsible for reviewing batch records for completeness• Reviews, troubleshoots and escalates Serious Quality Events (SQE’s)

Tokyo, Jp, Jp

• Product Quality Complaint handling, Product Quality Review / Annual Product Review, Product Recall, Incident Management, and support for the integration of new product acquisitions. Write SOPs.• Support the PQM Product Quality System alignment into single One Shire Quality System. Project and Change Management, Acquisition / integration / new products into and divestment of products out of the PQM Product Quality Systems.• Integration of One Shire Recall and Withdrawal processes. Integration of One Shire Board of Health Notification processes. Computer System Validation (CSV) (test script execution). • Execute the transition plan, Support One Shire APQR system integration (One shire workflow design, user testing, training and education, Go Live, Hyper care and subsequent required enhancements. • Support Regulatory in the delivery of the new YBPR Canadian requirements. Process validation. Create TrackWise reports.

Us

• Works with department managers to complete regulatory compliance including Consent Decree related steps. Determines strategy for execution of project goals and establishes milestones. • Maintains Regulatory Compliance SharePoint site, supports inspection readiness through Quality Assurance review of documentation, equipment and facility. Monitors activities to ensure regulatory commitments are met. • Develops project schedules, cross functional team deliverables, Performs gap analysis identifying and mitigating risk. Manage tactical aspects of Quality System project implementation.• Documents evidence of process and project steps completion and provides status report updates. Provides notification and escalation to Sr. Management as appropriate. • Makes recommendations to other team members, project managers and Sr. Management for the successful completion of project goals. • Review of CAPAs, Change Controls and Investigations through the Dashboard Compliance Metric process for sufficiency to close including effectiveness checks. • Emphasizes a zero defect work environment. Identifies areas for continuous Process Improvement.

Us

• Participates in supplier qualification process insuring alignment with McNeil Quality Expectations• Support Operational Readiness as needed• Compiles metrics, trending and other supporting documentation for FDA Monthly Status reports. • Support all Fort Washington, certification, regulatory and internal audits as needed• Maintains SharePoint site for Recall Team related documentation.• Serves on Recall Compliance team, documents discussion at meetings and distributes minutes.• Develops and maintains business relationships with vendors who provide services in support of Recall. • Conducts over-site review and compile metrics report regarding spend with vendors who • Provide services in support of Recalled McNeil Consumer Healthcare products. • Writes SOP’s and supports various projects. • Identification and implementation of best practices. • Assist in compiling request packages for termination of the Recall process for submission to the FDA. • Perform statistical and financial analysis of data.• Assist in the development of Quality Agreements with Vendors

June 2008 – CurrentDirector, Higher Standard Engineering Consulting Services Lansdale, PA 19446 • Providing engineering consulting services to the Biotechnology scientific community in the areas of laboratory science and manufacturing process technology including supply chain and information management, packaging and distribution for GLP/cGMP FDA regulated environments. • In addition to other services we can support Lean Six Sigma – process improvement, financial and statistical analysis and make versus buy, out sourcing, value stream mapping and process optimization projects. • We can also assist with the preparation for regulatory Pre and Post Pre Approval and Inspection (PAI) of manufacturing, warehousing and distribution areas. Review and validation of quality systems including (EDMS) electronic data management systems for compliance to FDA, ICH, GAMP 5 and ISO requirements. • Develop materials and provide in house, cross disciplinary training regarding supply chain and information management in support services and production environments. Topics of review include process improvement, implementing best practices, change management, impact analysis, regulatory compliance, safety, health and environmental concerns and quality control. • We are also available to write process technology curriculum for academic institutions and to assist in the validation and continuing validation of manufacturing processes, the writing of SOPs, equivalency memorandums, corrective and preventive action (CAPA), risk and change management and summary reports.

Providing management consulting services on a Pro - Bono basis to non profit human services organization in the areas of marketing, communications and development.

Bethlehem, Pa, Us

Completed graduate program in engineering which focused on strong math & science principles and practices as they apply to engineering concepts, improving quality, customer satisfaction and regulatory compliance.

• I have provided leadership in the area of operational excellence including efficiency, effectiveness of operations and continuous improvement. These initiatives have resulted in streamlined processes, a reduction in materials cost and work flow centered labor distribution. • Experienced in Supply Chain Management including procurement, receiving, warehousing and distribution in support of Drug Development and Manufacturing Operational Processes. Manufacturing Systems Engineering, Aseptic Cell Expansion, Filtration / Purification and Bio-Sterile Validation Manufacturing Processes. • Supervision for hourly employees who aid in the vaccine manufacturing process. Established quality circle and contingency planning team. Managed projects, shop floor metrics, quality assurance and regulatory compliance. • Other responsibilities include the writing of SOP’s, contracts for services, supplies and equipment, change request, corrective action reports (CAFU’s) and equivalency memorandums. Participation in pre and post Pre Approval Inspections (PAI) and new product launch activities including domestic and international product licensure.

Cell & Molecular Biology (Biotechnology)

M.S., Engineering

Mba, Business Administration

Doctoral Candidate Dmd Program, School Of Dental Medicine Dentistry

Bachelor'S Degree, Chemistry / Business