Robbie Morehead Project Manager

Transcription

1 Profile The consultant is an accomplished quality professional with 27 years' extensive medical device, pharmaceutical, regulatory, and Food and Drug Administration (FDA) experience. The consultant s experience spans in providing Program/Project Management, Computer Systems Validation (CSV) guidance, and quality technical leadership for Supply Chain projects in the pharmaceutical, biotech, and medical device industries. The consultant s projects focused on process, data, and information systems in the manufacturing area involving key compliance issues, such as: Good Automation Manufacturing Practices (GAMP), Computer Systems Validation (CSV), Information Technology Installation Qualification/Operational Qualification (IT IQ/OQ), and 21 CFR part 11. The consultant has broad experience in all aspects of a project, from developing requirements through design development, implementation, testing, startup, and validation. Experience FDA Quality and Regulatory Consultants LLC Present Conducts Project Management duties such as: kick off meetings and project status calls, completes meeting minutes and maintains the collaboration plan, fulfills both client and consultant needs Tracks deliverables/reports and updating project Stakeholders Evaluates the project against success criteria Conducts peer reviews of deliverables/reports and supports the needs of the FDAQRC Quality Management System (QMS) Conducts remote audits in technical areas of expertise, as needed Conducts peer reviews of deliverables/reports FDA Quality and Regulatory Consultants LLC 100 E. Whitestone Blvd., Suite Cedar Park, TX USA T: +1 (214)

2 Supports the needs of the FDAQRC quality Management System (QMS) Conducts remote audits in technical areas of expertise as needed Regulatory Leader Technical Systems Deloitte & Touche QMS Subject Matter Expert for major FDA remediation effort. Scope included the entire 21 CFR 820 regulation sub-systems Designed, developed and deployed of global processes, systems including organizational and change management initiatives. Successfully partnered with senior leadership to establish an overall project governance model representing cross-functional stakeholders Developed required program supporting documents such as work stream charters, scope statements of work, goals, approach, decision/escalation process, success measures, communication plan, key deliverables, with associated milestones and risks. Built detailed project plans with cross-functional teams to define tasks, timelines, resources and deliverables for each QMS subsystem Responsible for defining the vigilance of risk triggers that mitigate project risks and responsible for overseeing the risk management function for the company domestically and internationally. Coordinated/facilitated periodic team and executive leadership meetings; issued minutes defining discussions, actions and decision Managed the project team in designing, and rolling out the Integrated Business Planning processes and solution in the Systems Application Marketing (SAP) Integrated Business Planning solution Gilead Sciences Provide Quality Oversight of Quality Assurance (QA) Validations and responsible for reviewing and providing guidance to the project team on validation efforts and ensuring that the quality system is maintained and compliant to current regulations Responsible for ensuring that the Regulatory Compliance department maintains a defendable Quality System FDAQRC CV Robbie Morehead v1.0 CONFIDENTIAL Page 2 of 6

3 Responsible for working with the management team to determine the pros and cons of risks that have been identified based on overall compliance with a risk based approach Biomerieux Validation Team Lead on Site and leading remediation and compliance improvement activities for large International Pharmaceutical and Medical Device companies with FDA Consent Decree, Warning Letter, and 483 abatement needs Conducted Third-Party biweekly meetings Responsible for conducting risk assessments for each medical device line and presenting the findings along with a plan of mitigating the identified risks Created risk tables which were used as a template for evaluating risks and creating and presenting reports to senior management on regular basis Provided Subject Mater Expert (SME) review and creation of process and equipment validation protocols for manufacturing processes Oversaw the completion of operational qualification reports for Quality sign-off Implemented Discoverant and providing ongoing site support with analyzing the data Compiled labware data for stage processing Baxter Healthcare, Inc Support of the development, completion, logging and archiving of documentation on protocols, Validation Master Plans, and Validation Summary Packages for automation/controls and computer systems Developed best demonstrated validation practices within the validation department, based on current industry practices and guidelines Support continuous improvement within the quality department FDAQRC CV Robbie Morehead v1.0 CONFIDENTIAL Page 3 of 6

4 Assisted with regulatory submissions and regulatory agency inspections as required for automation and control system qualification Oversaw the qualification process for all related automation and control project implementations involving Programmable Logic Controller (PLC) and Distributed Control System (DCS) systems, along with Manufacturing Execution (MES)/Evidence Based Manufacturing (EBM) systems in addition to supporting the change control process for all related software changes Company representative for validation department to industry as required Served Tier 2 Work stream teams as required Oversaw Risk Analysis assessment deliverables for 510K Provided day-to-day support of the Automation and Controls Continuous Quality Verification (CQV) Program Responsible for SAS validation and compliance with respect to assuring that the data was clearly analyzed and adhered to the change control policies and procedures. Executed validation processes to ensure the control systems meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices Merck, Inc Responsible for developing a system(s) that will enable the manufacturing and information technology organizations to interact in a formal way that allows items to be tracked and monitored Responsible for applying Lean Six Sigma principles and drive process improvements that will result in better efficiency and cost-savings Serve as a subject matter expert (SME) for the Demand Management division for various projects and recommend solutions Serving as a subject matter expert (SME) for the training department (SRO) Assist with developing standard operating procedures FDAQRC CV Robbie Morehead v1.0 CONFIDENTIAL Page 4 of 6

5 Responsible for developing staff and working with internal departments to make sure that compliance is met and in accordance with regulatory standards Opened, tracked, and closed deviations Responsible for gathering Discoverant data and formalizing the information for senior management Work as a liaison with various departments for on behalf of the Training Department Internet Technology/Software Quality Assurance Clinical Trials Leader LabCorp, Inc Responsible for managing staff of 17 technical personnel that validate and test systems used by the clinical trials organization Managed, coordinated, lead and developed the directive to meet company, department and individual objectives Ensured continuous improvement of staff s performance through training, coaching, mentoring, and providing timely and accurate performance measurement Developed project plans, evaluates risk, and coordinates resources to meet requirements around product and software releases. Responsible for ensuring that Systems Applications Marketing (SAP) releases are validated and tested before being deployed into the production environment Served as SME on the Acquisition Team during all company acquisitions and for Discoverant installation and making sure that the application was compliant with the current corporate quality system Responsible for the SAS migration to SAS 9.2 and moving the legacy system(s) to the new windows platform. This effort also included validation and compliance Tracked and closed deviations on behalf of the site and ensuring that all paperwork is centrally located in the event of the audit. Ensured development and implementation of effective strategies for managing the processes, systems and tools necessary to produce solutions that meet or exceed customer requirements. Created and managed departmental budgets. FDAQRC CV Robbie Morehead v1.0 CONFIDENTIAL Page 5 of 6

6 Responsible for managing nine Offshore resources in conjunction with eight fulltime reports Oversaw company compliance for ISO standards Other Relevant Job Titles Technical, Information Technical Consultant, Director of QA Validation, QA/Validation Director, Global Leader of QA Validation, Executive Regional Consultant Education BS / Business Administration 1994 North Carolina Agriculture and Technical State University Certifications / Licenses Information Technology Infrastructure Library (ITIL) 2011 Axelos Systems Applications Marketing (SAP) 2010 SAP University Master Blackbelt Lean Six Sigma 2008 Villanova University 2007 George Washington University FDAQRC CV Robbie Morehead v1.0 CONFIDENTIAL Page 6 of 6