Stephanie L Skipper

MS, CMQ/OE, CQA, PMP Phone: 410-245-7237 Email: sskipper@tqmsllc.com

Career Objective
Certified and experienced Leader and Management Professional with 8+ years quality assurance experience in the Biotechnology/Biopharmaceutical industry; 11+ years project management experience involving complex technical projects. Seeking role responsible for implementation and management of business strategies and goals, cost savings, and overall business process improvement. 1099 Independent Contractor/Consultant structure preferred.

Sample of Significant Achievements

Design and commissioning of a GLP/GMP quality system, a GCP quality system and performance as a subject matter expert/consultant for the design and implementation of an ISO 13485:2003 quality system Direct and coordinate various aspects of management operations including but not limited to, providing departmental leadership and direction, budgeting and cost reduction, implementation and revision of standard processes and procedures, providing and or ensuring appropriate training for personnel ensuring efficient and high quality execution of work Proactively assumed responsibility for $750,000.00 federal program that was in jeopardy of losing funding due to accountability issues. In one year brought program into complete accountability with federal and state regulations while achieving improved integration with organizational goals and processes Prevented $210,000.00 loss and rescued failed project by taking the initiative to develop and recommend a project plan, then assume responsibility for project execution and success. Generated $1.425 million in revenue in a single month, successfully managing clinical packaging for 22 concurrent projects Lead Cost of Quality initiative targeting $500,000 reduction in price of nonconformance

Education and Certifications

Master of Science, Quality Assurance and Regulatory Affairs Temple University School of Pharmacy MBA Foundations (Core Courses Only 18 Credits) Temple University, Fox School of Business Bachelor of Arts English (with Honors)/Biology Minor Temple University Certified Quality Auditor American Society for Quality (ASQ) Certified Manager of Quality/Organizational Excellence American Society for Quality (ASQ) Project Management Professional Conferred: May 2005 May 2001- Aug. 2003 Transferred to Sch of Phrmcy Conferred: Jan. 2001

Valid: Dec. 2007 Dec. 2010 Valid: Oct. 2008 Dec. 2011

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Project Management Institute (PMI)

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Soft Skills
Proven ability to analyze business and regulatory requirements then identify strategies to achieve goals. Creative problem solving including identification of root causes of problems and proactive advocate and leader in identifying and promoting solutions Strong organizational management, planning, strategizing, and communication skills Clear understanding of best business practices with respect to operations management, program/project management and quality management methodologies Excellent written and verbal communication skills Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment

Employment History
CSC Government Health Services Division | DVC Frederick MD Business Process Operations Special Projects March 2006 to Present

Responsible for strategic projects, developing and implementing company-wide processes, policies and systems supporting improvement in business operations Research and write policy statements, SOPs and direction sheets Work with Executive Management, Senior Management and Department Heads to identify, and implement strategies from established methodologies (PMBOK, TQM, QBOK, ISO, QSIT, etc) to streamline business operations, training, compliance, and management oversight Resolve operational inefficiencies identified in the 2008 Gap Analysis conducted by BPO Bridge Clinical QA team experience gaps related to business processes, GMPs, Laboratory Equipment Validation and Computerized System Validation and assisted CQA supervisor by picking up overflow work from other team members

Clinical Quality Assurance Manager Quality Assurance subject matter expert and auditor for assigned clinical project teams supporting phase 1 through phase 3 bio-defense vaccine studies conducted in the United States and Europe Lead and contributor roles for development of clinical plans, essential documents, specifications and study specific procedures Work in tandem with clinical project manager to oversee all aspects of clinical studies Assist management of cost, scope and schedule by holding parties accountable for contractual responsibilities and adherence to project specifications and regulatory requirements Ensure that clinical operations are conducted in accordance with internal SOPs and external regulations and ensure that external partners are operating within requirements set forth in regulations, project specific plans, specifications and contracts Assess and provide input related to validation strategy for 21CFR11 compliant electronic data capture systems and clinical databases Evaluate all third party CDISC specifications for the company Member of biosurety, biosafety and risk mitigation strategic teams with specific responsibilities to feasibility, biosafety, and risk mitigation planning for building a US based vaccine manufacturing facility utilizing an H5N1 (avian) whole virus construct

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Participate in and lead internal, client/sponsor, scientific and other presentations as required Worked with the Director of Clinical Operations to create a functional Clinical Operations Statement of Work template for future subcontracting opportunities Provide technical and business assessments of relevant new technologies and procedures and provide recommendation to senior executives for improvement and development of department Promote intra-department and inter-department efficiencies, data quality, and profitability Assist with purchase planning, vendor evaluation, validation and implementation planning for companys first Electronic Document Control System Bridge Clinical QA team experience gaps related to business processes, GMPs, Laboratory Equipment Validation and Computerized System Validation and assisted CQA supervisor by picking up overflow work from other team members June 2004 to Present

Consultant Quality System Design and Development

As business owner, responsible for business strategy and management decisions, contract and proposal writing, technical reports, EVM, budgeting and operations, and oversight of contracted personnel Responsible for managing the project scope of work and ensuring that timelines, deliverables and client expectation are met as agreed Develop project plans and to establish project milestones and establish communication processes Work with subcontractors and client personnel to ensure delivery of a quality project Assure the quality of all work done on the assigned project by establishing quality control procedures and ensure adherence to all standard operating procedures Identify scope changes and secure agreement from sponsor for payment before performing any out of scope work Past Clients NuGEN Technologies, Inc (2006 2008) Perform assessments of quality system, including gap analyses, to develop and implement ISO 9001:2000 quality system for analytic reagent manufacturing Managed scope change resulting in successful ISO 13485:2003 registration Writing and execution of Validation Plan for temperature monitoring system Interim Director of Quality Assurance Commissioned GCP QA Department Created quality system documentation (Quality Manual, Validation Master Plan and Standard Operating Procedures) for start-up phase I/IIa clinical trial facility Validation of Perceptive Informatics electronic data capture system and Reese Scientific temperature monitoring system

Shin Nippon Biomedical Laboratories (2005)

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Morphotek, Inc Exton, PA Associate Director, Quality Assurance (contract position)

February 2004 to July 2005

Commissioned GMP/GLP/GCP quality assurance program for start-up biotech to manage QA activities associated with R&D efforts, technology transfer, GMP manufacture, pre-clinical development and clinical development of therapeutic monoclonal antibody products Participate in corporate strategic planning, and lead initiatives, departmental staff and budget management Participated on senior management strategic teams supporting Investigational Product selection, manufacture and development from R&D stage through phase I clinical studies Member of Biosafety, Validation, Clinical Development and IND/CMC strategic teams Lead multidisciplinary teams for complex investigations for CAPA and or to obtain timely data from which defensible decisions could be made for drug development projects Represented company externally by communicating with regulatory authorities (eg FDA during regulatory inspections and pre-IND meetings), business partners, contract research organizations, contract manufacturing organizations and participating on professional committees Provided regulatory affairs guidance for 8 months while company searched for Regulatory Affairs Director Responsible for release/rejection of components, active pharmaceutical ingredient (API), bulk drug substance (BDS), finished dosage form (FP), and container closure systems (aseptic manufacturing for parenteral products) Established stability programs for bulk API and finished drug products Lead quality staff and quality initiatives including audit program, training program, CAPA and continuous improvement January 2003 to February 2004

Bio-Imaging Technologies, Inc Newtown, PA Clinical Project Manager/Quality Assurance Compliance Group Mgr

Responsible for managing the project scope of work and ensuring that timelines, deliverables and client expectation are met as agreed Develop project plans and to establish project milestones and establish communication processes. Work with core team members and other individuals from other departments to ensure delivery of a quality project Manage internal resources to ensure the appropriate management and delivery of the final work product Oversee all project activities from start-up to delivery of the final methodology report Assure the quality of all work performed by establishing quality control procedures and ensure adherence to all standard operating procedures Identify scope changes and secure agreement from sponsor for payment before performing any out of scope work Provide guidance for professional development of staff. Coordinate resource distribution, make hiring recommendations, lead disciplinary actions, and deliver performance reviews Participate in and lead internal, client/sponsor, scientific and other presentations as required Coordinated and managed activities associated with the acquisition, processing, read sessions and data output deliverables for the medical imaging component of clinical studies for corporate clients in the pharmaceutical, biotechnology and medical device industries

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Technical and regulatory writing in the form of project specific work instructions, communications documents, workflow and specifications documents, imaging guidelines, project status reports, methodology reports, computer assisted masked read (CAMR) outlines and export specification outlines As a member of the Quality Assurance Compliance Group, assisted the Director of Quality Assurance in identifying internal quality control issues and in formulating and implementing solutions Facilitated client audits and prepared written documentation such as project specific work instructions, project specific SOPs, and other audit related follow-up and supplemental documentation

Quintiles Transnational Corporation Mount Laurel, NJ July 2001 to December 2002 Project Manager Coordinated and managed GMP activities associated with the design, packaging, storage, distribution, return and destruction of phase 1 through phase 3 clinical study IP and supplies including controlled substances Identification and procurement of appropriate supplies to accomplish package design, maintain product stability and protect blind integrity Responsible for managing the project scope of work and ensuring that timelines, deliverables and client expectation are met as agreed. Oversee all study activities from start-up to delivery of the final study report Develop project plans and to establish project milestones and establish communication processes Work with core team members and other individuals from other departments to ensure delivery of a quality project Manage internal resources to ensure the appropriate management and delivery of the final work product Assure the quality of all work done on the assigned project by establishing quality control procedures and ensure adherence to all standard operating procedures Identify scope changes and secure agreement from sponsor for payment before performing any out of scope work Girard College Philadelphia, PA Federal Programs Coordinator/Project Manager January 1998 to July 2001

Administrator of five federally funded and three state funded educational programs with grant budgets in excess of $850,00000 as well as Educational Department budget in excess of $190,00000 Developed program objectives, policy and procedures Direct personnel activities, and provide guidance for professional development of staff (coordinate resource distribution , make hiring recommendations, lead disciplinary actions, deliver performance reviews) Integrate and coordinate long and short-term project and program functions with goals and curriculum Redesigned and implemented progressive and accountable Title I program, facilitate cohesion of staff and sub-programs Proactively assumed responsibility for $750,00000 federal program that was in jeopardy of losing funding due to accountability issues. In one year brought program into complete accountability with federal and state regulations while achieving improved integration with institutional goals and processes

Experience prior to 1998 as a paralegal