Shannon Harrell Email & Phone Number

Basking Ridge, Nj, Us

Daiichi Sankyo, Inc (DSI) standard of business conduct invokes global values of innovation, integrity and accountability. These are fundamental principles for delivering and progressing innovative R&D and clinical research which are shared by every company employee each and every day. Together our values and standards of business conduct form the foundation of the company’s compliance program and how we choose to conduct business.I was hired by DSI to facilitate development and delivery of clinical research process changes while working globally with all Operational Groups within Phase I-IV. Supporting business and IT management with assessing, developing, and facilitating department operations for delivering compliant technology solutions associated with, but is not limited to relevant systems (financial reporting/transactions, clinical research, central lab operations, regulatory submissions management, R&D, and QMS) processes and their outcomes comply with standards that meet applicable domestic and international regulations, guidelines, and satisfy client and company requirements. Standardizing business practices related to electronic document management across GCP/GLP/GMP disciplines, including R&D capabilities; enabling business process efficiencies and providing the tools to manage the end-to-end lifecycle of business operations.For a detailed list of my accomplishments and expertise in specific areas, please request my resume.

Susquehanna Global Compliance Resource Center (SGCRC, LLC) provides quality assurance, regulatory compliance and validation services assuring cGMP comprehension within the pharmaceutical, biotechnology, and medical device industries to provide quality improvement solutions. We offer exceptional leadership abilities and have demonstrated the capacity to build, train, and mentor highly productive and motivated cross-functional teams and departmental personnel. Our quality assurance and quality control services provide unequivocal, unrivaled, and extensive experience to meet the full scope of regulatory requirements, quality standards and industry best practices across research and development, clinical studies, supply chain, and commercial operations including OTC and Rx manufacturing.The success of SGCRC is attributed to working in a multicultural and cross-functional environment encompassing, but not limited to, point of service, logistics, or resources.My diverse clientele has further broadened my level of expertise to also include:• Technology Development & Transfer• Business Integration Solutions• Clinical Trial Management• Operational Controls & Procedures• GxP AuditsFor over 20 years, I have offered Management Consulting Services to my clients in a broad array of professional backgrounds in addition to the pharmaceutical and bio-medical industries. I provide comprehensive knowledge and expertise in Quality Assurance, Quality Control, Regulatory Compliance, Validation, and Project Management. For a detailed list of my accomplishments and expertise in specific areas, please request my resume.

West-Ward Pharmaceutical caters to an open culture consisting of friendly people and an enticing environment. We value our relationships with our customers, and our sales representatives and customer service teams are organized specifically to make our world class manufacturing facilities work in the best way for you. Our goal is to have increased access to affordable healthcare by manufacturing and distributing the highest quality pharmaceutical products. http://west-ward.com/I am a Senior Consultant responsible for assisting the business, IT and Validation departments with achieving compliant technical solutions for new projects, quality improvements, and continual operations.Key Achievements:• Assisted with the leadership and management of global Information Security awareness, training, and inspections.• Provided direction and support for audit and inspection readiness activities for IT related systems and operations control.• Assisted with development and delivery of QMS (e.g., change management program) and governance, risk and compliance relative to Information Systems.• Worked globally with all operational groups covering central lab operations, clinical research, legal, R&D, manufacturing and distribution processes and their outcomes comply with applicable standards, including domestic and international regulatory requirements• Managed SAP hosting relocation project, including systems integration projects from new company acquisitions, mergers and reorganizations.For a detailed list of my accomplishments and expertise in specific areas, please request my resume.

New Brunswick, Nj, Us

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. http://www.jnj.com/For Johnson & Johnson, I was hired as the Lead Consultant on their IT Computer System Validation (IT CSV) projects. I was responsible for leading three key teams in the Consumer Health Division: the Lead Investigation Team, which reports CSV test defects; the Lead Compliance Review Team, which delivers the CSV Post Execution Review; and oversight of the Cognos Reports design, development, and implementation for GMP use. I later transitioned to IT QA in support of authoring, reviewing, and approving investigations and CAPAs related to processes and computer systems.Key Achievements:• Development and implementation of a CSV test defect process• Delivering Consent Decree projects ahead of project schedule• Developmental Assistance of quality metrics/trackerFor a detailed list of my accomplishments, please request my resume.

Norwich, New York, Us

Norwich Synchronized Outsourced Solutions, offering complete services for a product’s entire lifespan: from development, clinical research, and formulation to commercialization and manufacturing. http://www.norwichpharma.com/Not part of my consulting services, I was hired as Department Manager of Quality Assurance Regulatory and Compliance, responsible for overseeing the Quality Management Systems and Personnel and reporting to the Vice President of Quality Assurance. Responsible for quality information systems and integration of regulatory and compliance functions (e.g., regulatory licensing and permitting, and pharmacovigilance) including GMP training. Provides consultation and leadership to customer new business initiatives and support executive management directives in order to ensure full compliance with regulatory agencies such as European Commission, Food and Drug Administration, Health Canada, ANVISA, in support of prescription and OTC products, and medical devices.I was a member of the following boards and committees:• Change Management Program• Quality Council• Leadership Council• Project CharterKey Achievements:• Revamped Supplier Quality and Internal Auditing Programs• Overhauled Customer Complaint and Annual Product Review Programs• Spear-headed the remodeling of the Validation Department and implemented a Risk Management ProgramFor a detailed list of my accomplishments, please request my resume.

Princeton, New Jersey, Us

RadPharm is a leading full service imaging core lab, managing all facets of the imaging segment of global clinical trials, Phases I-IV. RadPharm is a founding company of CoreLab Partners which has since merged with BioClinica, Inc. For more information, please visit http://www.bioclinica.com/.Hired as a Senior Validation/Quality Assurance Consultant for RadPharm, I helped the lab facilitate and support project assessment teams that were responsible for successfully executing project charters, project planning, business analysis, software vendor audit, and risk assessment.Key Achievements:• Provided a framework for analyzing industry best practices• Optimized CAPA process, performance, tracking, and delivery• Developed pre-audit assessment form facilitating process improvements and audit readinessFor a detailed list of my accomplishments, please request my resume.

Kenilworth, New Jersey, Us

Schering-Plough was a United States-based pharmaceutical company which merged with MSD to create a stronger, more diverse and more truly global company. It has since merged with Merck & Co. and taken the name of Merck & Co.For Schering-Plough, I was hired as a Senior Compliance/Quality Assurance Consultant overseeing Research and Development, Clinical Research, Commercial Operations, and Global Quality Information Systems Support.Key Achievements:• Devised and implemented various programs (GCP audit, periodic review, and software vendor assessment)• Developed Quality Management templates (i.e. plans, reports, checklists, assessments, questionnaires, and matrixes, etc.)• Developed and instituted global SOPs for Change Management, Configuration Management, Clinical Programming and Data Management, and Quality ControlFor a detailed list of my accomplishments, please request my resume.

Master Of Science (Ms), School Of Pharmacy/Regulatory Science

Bachelor'S Degree, Electrical And Electronics Engineering