NANCI A. HAYWARD North Springs Drive Dunwoody, Georgia

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1 1595 North Springs Drive Dunwoody, Georgia Summary Over 25 years of team building, goal oriented management, and direct industrial experience using project management to achieve quality, regulatory compliance and product development in the areas of biotechnology, devices and bio-pharmaceuticals. Maintain solid experience in operations management, customer service, regulatory and quality assurance, quality process management and re-engineering, and training development. Demonstrated ability to promote company goals and image. Strong communication skills with staff, management and customers. Proven ability to recruit, train and motivate staff. Demonstrated ability to develop and implement quality systems at a corporate level. Consistent high performance evaluations for independent decision making, work output, interpersonal skills and management ability. Proven ability in strategic leadership with team focused alliance building to include a strong financial and business acumen. Accomplishments Managed production, quality, validation and Good Manufacturing Practices compliance (US Food & Drug Administration, European Regulatory Authorities) programs of established pharmaceutical companies. Developed and directed quality systems program for multi-national, multi-site biologic-based company with sales over $123 million dollars. Directly interacted with Food & Drug Administration and European Regulatory Authorities on facility audits for pre-license inspection and annual inspection, responses to regulatory observations and industry-government workshops. Developed and executed a quality management program for a plasma pharmaceutical development company. Built the quality management team for donor centers and corporate offices to include the hiring and training of personnel, creation of job descriptions, and structuring of the quality processes. Designed and implemented a Total Quality Management System using an off the shelf GXP compliant application for web-based document control, training management and exceptions management. The application was configured to meet business needs and if fully 21 CFR Part 11 compliant. Presented at local, state, national and international industry meetings. Developed and coordinated global quality assurance activities for international clinical trials laboratory. Re-engineered the quality system within the clinical trials laboratory to make it a more efficient tool providing continuous improvement metrics to the business operations. Key driver in the evaluation, gap analysis and remediation of Laboratory Information Systems and other regulated applications for compliance to 21 CFR Part 11. Directed the global quality system for a global network of central laboratories operating on a budget of $2.5 million dollars. Assisted with the establishment of central clinical trials laboratories in Beijing China and Mumbai India, providing quality assurance oversight of the operations from inception through successful launch of the facilities. Managed and provided technical expertise for high production blood center while maintaining excellent regulatory compliance. 1

2 Relevant Experience: Dragonfly Consulting, LLC ~ A Total Solutions Company ~ Atlanta, GA Dragonfly Consulting provides clients with a full package solution for the areas of regulatory, quality, and process improvement. Dragonfly provides interactive ideas and solutions for the client, while involving staff in the process. Collaboration with clients ensures that the business vision and strategic goals are realistic to production improvements and enhance cost control while driving the success of the project at hand. Dragonfly consultants have expertise within the biologics, pharmaceutical, biotech, laboratory and clinical trials arenas. Consultants are skilled in the performance and management of internal, external and vendor audits, and in the preparation of a facility for such which involves training within the regulations applicable to the business function. Consultants have proven success in establishing and maintaining a total quality management system. Consultants understand equipment and regulated systems validation processes, requirements and regulations to present President and Partner, Dragonfly Consulting, LLC ~ A Total Solutions Company ~ International BioResources, LLC Atlanta, GA International BioResources is a plasma pharmaceutical development company headquartered in Lafayette, LA to 2010 Senior Vice President, Regulatory Affairs / Quality Assurance & FDA Authorized Official 2007 Vice President, Regulatory Affairs / Quality Assurance & FDA Authorized Official Provided direction, management and oversight of the quality program and regulatory compliance for the company. Provided strategic direction and leadership to ensure that company goals were met. Directed the quality program to include audit management (internal, external and agency / client), process and performance improvement, exceptions management and assured that there were current, relevant and appropriate standard operating procedures. Created the Regulatory Affairs/Quality Assurance Corporate department from zero regular employees to a staff of 44 managers and directors. Interviewed, hired and trained the staff. Directed the interviews, hiring and training for the center Quality Supervisors (2-3 per center) for 48 centers. Established the IT Regulated Business System Department, with a staff of 9 individuals. Directed the regulated systems validation programs. Selected and implemented an integrated Quality Management System encompassing Document Control, Training Records Management, Audits and CAPA in all 48 centers and 2 corporate locations. Participated in the selection of new business partners. Managed the European audit and certification programs, acting as the direct liaison with the Regulatory Authorities. 2

3 Acted as the Executive Sponsor and Regulatory expert for the project design, pilot and implementation of an electronic donor questionnaire. Served as Alternate Authorized Official/FDA in the absence of the Authorized Official. Quintiles Laboratories Worldwide, Atlanta, GA Quintiles Laboratories conducts analytical testing for patients enrolled in pharmaceutical clinical trials. Quintiles Laboratories supports each pharma trial through project management and ongoing to final data transmission Vice President, Quality Assurance & Regulatory Compliance Provided direction and management of the quality assurance and regulatory compliance program for Quintiles Laboratories Worldwide, ensuring that processes are globally harmonized and consistently conducted. Ensured that QA within each location (Scotland, United States, South Africa, China, Singapore, India and South America) were provided with strategic direction, appropriate staffing and education in order to satisfy regulatory and client requirements. Ensured that all activities were designed to confirm operational compliance with relevant drug, device, manufacturing, and biotechnology regulations, company policies, procedures, Corporate Risk Management & QA Department expectations, and customer requirements to 2007 Senior Director, Global Quality Assurance and Regulatory Compliance Provided direction and management of the quality assurance and regulatory compliance program through Quintiles Laboratories Worldwide, ensuring that processes were globally harmonized and consistent. Ensured that QA within each location (Scotland, US, South Africa, China, Singapore and South America) were provided with strategic direction, appropriate staffing and education in order to satisfy regulatory and client requirements. Provided direct oversight for US facility with oversight via site managers at remaining laboratories worldwide. Provided regulatory guidance for all applicable US, EU and country specific requirements. Coordinated client audits and responses for all sites. Hosted / co-hosted regulatory audits from the Food and Drug Administration (FDA), State of GA, State of NY, College of American Pathologists, MHRA (Medicines and Healthcare Products Regulatory Agency), Drug Enforcement Agency (DEA), and Federal Aviation Administration (FFA). Participated in the evaluation of affiliate laboratories, and maintain quality oversight for those currently in place. Served as a member of Quintiles Transnational Global QA Team, participating on committees and weekly conference calls as appropriate. Acted as the QA liaison for Business Development for RFI (Request for Information) and bid defense to 2002 Director, Quality Assurance and Regulatory Compliance for the Americas Provided direction and management of the quality assurance and regulatory compliance program through all departments at Quintiles Laboratories, Ltd. (QLAB), a division of Quintiles Transnational. Ensured that procedures, systems, facilities and data were compatible with company policies and procedures, relevant regulations and guidelines, and with the written commitments made to customers. Ensured complete traceability of clinical trial throughout life of study. 3

4 Maintained direct responsibility for the maintenance and successful functioning for the Global Document Control System for Standard Operating Procedures (SOPs), for all 5 worldwide QLAB sites. Maintained direct responsibility for ensuring adherence to the Company Core Quality Standard (based upon the principles of Good Practice (GLP, GCP, cgmp), ISO, CLIA and College of American Pathologists [CAP]) for the Atlanta, GA facility and for the Quintiles Latin American facility in Buenos Aires, Argentina. Responsible for managing the internal and external audit programs, the incident and complaint systems and ensuring that all aspects of study design were properly adhered to and study conduct is above reproach. Served as the direct liaison for customer and regulatory audits, and provided regional audit oversight for the affiliated subcontractor laboratories located in South America, and for all subcontractor laboratories and critical vendors. Ensured that licensure and accreditations are maintained, and provided oversight for the proficiency testing for the laboratory. Provided ongoing training for the company employees in quality, compliance and regulatory areas. Provided direct supervision for 12 employees encompassing the areas of Records Control (SOPs, medical records including raw data, study documents and all off-site storage), quality systems, auditing, and regulatory compliance. Indirect oversight of the Quintiles Buenos Aires facility for quality system training and compliance. Alpha Therapeutics, Los Angeles, CA Alpha Therapeutics had as one of its divisions the Alpha Plasma Centers, which collected plasma from paid donors for manufacture into a variety of therapeutic products Director, Quality Assurance Provided direction and oversight to Alpha Plasma Centers (APC) to assure that all quality goals were met for all operational units within the APC division, to include regulatory requirements were met for any products manufactured. Ensured regulatory compliance and support quality initiatives through oversight/ coordination of documentation and change control, including review and approval of Standard Operating Procedures (SOP s) for the division. Performed and reviewed internal and external audits at donor centers, the testing laboratory, QA laboratory and storage facilities to evaluate manufacturing procedures that may affect donor safety and quality products and determine what actions were needed to improve process control and regulatory compliance. Determined the resources necessary to reconstruct the Quality Assurance Department and implement these changes / additions to enhance the current program. This included but was not limited to: SOP development and implementation, QA training and certification, validation / revalidation, statistical analysis, development of a customer complaint system, re-invention of a document control process and creation of a system for review of all reports to determine adequacy of investigations and identification of ways to improve operations. Serologicals Corporation, Clarkston, Georgia Serologicals Corporation in GA consisted of 3 major areas: specialty plasma production, source plasma production and collection of plasma for in-vitro diagnostic use. 4

5 1997 to 2000 Director, Quality Programs & FDA Alternate Authorized Official Provided oversight for corporate quality programs and liaison with operational components to ensure that all regulatory requirements for any products manufactured were met, including, but not limited to, source plasma, whole blood and blood components, and in-vitro diagnostic products. Ensured regulatory compliance and supported ISO initiatives through oversight/coordination of documentation and change control as ISO management representative. Established a program to ensure all aspects of FDA Guidelines for Quality Assurance in Blood Establishments (current version) were met, including a comprehensive program of validation/revalidation that ensured all equipment qualified before use and processes are optimal as well as adequately documented. Developed and maintained the strategy to pursue ISO 9000 registration. Performed and / or reviewed internal and external audits from donor centers and other manufacturing sites to evaluate manufacturing procedures that may affect donor safety and quality of products and determine what actions are needed to improve process control and regulatory compliance. Approved new and revised SOPs and process changes; assured that adequate SOPs existed for all manufacturing procedures for Source Plasma and any other products manufactured. Key driver in the design and implementation of an electronic document control system. Reviewed all reports of errors, incidents, lab failures, and customer complaints to determine adequacy of investigations and to further identify ways of improving operations. Provided periodic reports to management of trends and make recommendations for process improvement and error prevention. Provided guidance for the development of a computer system to meet 510k requirements. Prepared documents for submission to FDA and met with FDA to establish the plan for meeting the 510k requirements. Prepared annual report in conformance with 21 CFR (e). Supervised 6 Quality Managers and Quality Program Administrator. Provided expert opinion in the interpretation of GMP and promote increased GMP understanding at all levels. Served as Authorized Official/FDA in the absence of the Vice President, Regulatory Affairs to 1997 Technical Director United Blood Services, Fargo, North Dakota United Blood Services is a division of Blood Systems, Inc located in Scottsdale, AZ. The company maintains volunteer blood donor centers throughout the country and is the second largest whole blood donor program in the US. Responsible for all technical aspects of an active blood center of 37,000 whole blood donations and 3500 plateletpheresis donations. The position provided technical direction and expertise to assure the efficacy of blood components produced within policies, goals and guidelines (including FDA / cgmp, American Association of Blood Banks [AABB], CLIA). Scope included supervision and training of 60+ employees, administration of procedures to include those found in human resources guidelines, participation in hiring and evaluation of technical personnel, providing continuing education for staff and hospital personnel, interacting with and providing information to transfusion service personnel and physicians, and assurance of overall technical compliance. Consistently high compliance performer with regulatory agencies. Served as an R&D center for new products and services, often corresponding directly with the vendor, and introducing the product/service to local customers. 5

6 Actively participated in special projects for corporate office to include serving as a 3 year member of the Testing Field Advisory Council. Duties included writing, editing and approving SOPs, pilot project and validations. Served as a technical trainer and cgmp instructor for other centers within UBS system. Participated in an HIV study for the National Institute of Health (NIH) during the early phase of HIV testing on blood donors. Worked with Executive Director and Community Resources Director to increase awareness of the volunteer blood donor program, and with that presented at numerous luncheons about the program and traveled to all service hospitals routinely to meet with hospital administration. Provided continuing education to hospital staff (nursing, laboratory and physician groups) to 1989 Technical Supervisor Responsibilities included hiring and training, scheduling, supervision and evaluation of laboratory personnel; providing opportunities for continuing education; auditing and maintaining appropriate stock levels of laboratory supplies and reagents. Coordinated activities to assure timely testing, processing, and labeling of all donor units / components. Effectively implemented multiple new required FDA tests as directed through FDA guidance memoranda. Fargo Clinic, Fargo, North Dakota Fargo Clinic, now part of the Sanford Health System, began as a physician owned clinic that offered a full laboratory test menu and supported the hospital located within the same campus to 1985 Blood Bank Technologist Performed all facets of testing to prepare blood components for infusion, including crossmatching, antibody screens, solving antibody problems, performing antibody titration and antigen typing. Required to maintain a good working relationship with other departments, patients, and reference laboratory personnel. Assisted with the practical and technical instruction of medical technology student interns to 1980 Blood Bank Technologist Sioux Valley Hospital, Sioux Falls, South Dakota Tertiary care hospital group now known as Sanford Health System. Responsibilities included routine crossmatches and antibody screens, solving of crossmatch problems, and processing and labeling of donor blood. Also drew donors and prepared components. Assisted with maintenance of stock levels of plasma components. Education B.A., (Cum Laude) Southwest State University, Marshall, Minnesota. Major: Biology, Medical Technology Minor: Chemistry, English, Music 12 Month Internship for Medical Technology, Sioux Valley Hospital, Sioux Falls, SD Certified by ASCP and ASMT Technologist in Blood Banking Certified by ASCP:

7 Multiple technical workshops including National AABB, PPTA (ABRA), SQA, DIA, State ASCLS, State AABB meetings. Multiple management seminars/workshops including: Team Building, Supervision, Total Quality Management, Performance Appraisals, Conflict Management, Customer Service, cgmp, Quality Assurance, FDA and FDLI sponsored workshops. Professional Affiliations American Association of Blood Banks American Society of Clinical Laboratory Scientists - North Dakota Society of Clinical Laboratory Scientists American Society of Clinical Pathologists National Certification Agency Society of Quality Assurance Drug Information Association American Society of Quality Plasma Protein Therapeutic Association (formerly American Blood Resource Association) Offices Held / Activities Presenter: AABB (American Association of Blood Banks), New Orleans LA, 2009 Presenter: GSABC (Global Services for America s Blood Centers), Phoenix AZ 2009 Board Member: PPTA (Plasma Protein Therapeutics Association), 2007 to 2010 Member: PPTA Working Group, Presenter: DIA (Drug Information Association), Mumbai India, 2006 Auditor: College of American Pathologists (CAP), 2006 Presenter: IIR (International Institute of Research) National Meeting, Las Vegas, NV, 2005 Member: GMP Committee, SQA (Society of Quality Assurance) 2001 to 2004 Presenter: AABB (American Association of Blood Banks) 2000, 1999 Presenter: ABRA (American Blood Research Association) 1999, 1998 Member: Quality Assurance Committee / ABRA 1997 to 2000 Presenter: NDSCLS (North Dakota Clinical Laboratory Scientists) 1997, 1996, 1995, and 1994 Presenter: MABB (Minnesota Association of Blood Banks) 1996 Presenter: LEND (Laboratory Education for North Dakota) 1993, 1992 Area Key Contact, NDSCLS 1991 to 1997 Co-Chairperson - Registration Committee, NDSCLS 1994 Spring Meeting Co-Chairperson Exhibits, Minnesota Association of Blood Banks Fall Meeting

8 Advisory Committee Board Member, LEND (Laboratory Education for North Dakota) 1988 to 1993 Member, Public Relations Committee, NDSCLS 1991 to 1992 Immunohematology Scientific Assembly Chair, NDSCLS 1987 to 1992 Exhibit Committee Member, Minnesota Society for Clinical Laboratory Scientists (MNSCLS) Spring Meeting 1992 Co-Chairperson, Tri-State CLS Meeting, 1985 Professional and personal references available upon request. Name change to Hayward from Busse in