Quality Assurance Management

Ticalion

Stephanie L. Skipper Quality Management Services

Principal Consultant

Raise Efficiency • Align Operations

Realize Business Potential

QUALIFICATION SUMMARY: Mrs. Skipper has over seven years of direct, hands-on experience

in leading the design, development and management of quality assurance and quality

management systems including the commissioning and oversight of GMP/GLP, GCP,

registered ISO 13485:2003, registered ISO 9001:2008 and IT Biomedical (Medical Device)

quality management systems. Mrs. Skipper has a Master of Science in Pharmaceutical

Quality Assurance and Regulatory Affairs from the Temple University School of Pharmacy.

Mrs. Skipper has attained professional certifications in Quality Auditing, Quality Operational

Management, Project Management, and IT Service Delivery.

As a Principal Consultant at Ticalion Quality Management Services, LLC (June 2004 to

Present), Mrs. Skipper deploys and remediates quality management systems to support

global regulatory compliance requirements, third party certification/registration and

organizational business process improvement. She performs assessments (audits) of systems

and data to assists customers with establishing system baselines, eliminating systemic

deficiencies. Mrs. Skipper specializes in working with clinical trial sites, contract research

organizations and sponsor companies that are at risk for FDA enforcement action (483 s,

warning letters, consent decree, and application integrity process) to develop appropriate

responses and to implement comprehensive Corrective and Preventive Action (CAPA)

strategies. Mrs. Skipper’s expertise and experience include complex risk assessment and risk

management, biosurety/biosafety BSL 1-4, validation (cold chain, laboratory equipment,

computerized systems, and process), quality audit to support clinical trial data submission

and Corrective/Preventive Action.

EDUCATION

M.S., Quality Assurance and Regulatory Affairs, Temple University School of Pharmacy, 2005

M.B.A. Foundations, Temple University Fox School of Business; 18 cr. core courses only, 2003

B.A., English, Temple University, 2001

CERTIFICATIONS

ASQ Certified Quality Auditor (CQA) 2007 to present

ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), 2008 to present

PMI Project Management Professional (PMP) 2009 to present

ITIL v3 Foundations 2010 (no exp)

PROFESSIONAL ACTIVITIES:

Accepts invitations to serve on the ASQ Certified Quality Auditor Exam Committee

Accepts invitations to serve as a preliminary round judge for the ASQ International Team

Excellence Award

855 Santmyer Drive SE • Leesburg, Virginia 20175 • USA • Phone: 410-***-**** • Web: www.tqmsllc.com

PAST PERFORMANCE

American Red Cross Project with CSC North American Public Sector (November 2009 to

Present), Mrs. Skipper deployed and maintained a tailored quality management system that

is compliant with requirements documented in Title 21 of the Code of Federal Regulations

for medical devices and blood products including but not limited to 21CFR820, 21CFR 210,

21CFR211, 21CFR11, and 21CFR606 and the American Red Cross-FDA consent decree

requirements. The quality system attained and maintains ISO 9001:2008 registration. Mrs.

Skipper assured that program activities are in compliance with regulatory requirements

including validation requirements for IT infrastructure classified as medical devices. She

develops and oversees the maintenance of quality assurance documentation including

quality metrics. She developed and maintains the quality system manual, quality plan and

directs the implementation of the manual and plan. She determines quality department

staffing needs and maintains appropriate staffing levels. She manages and mentors quality

assurance staff. She directs internal and external quality audits. She interfaces with CSC’s

customer (the American Red Cross) as to resolve quality concerns and to facilitate third

party and FDA audits of the American Red Cross as related to CSC’s work for the American

Red Cross.

Computer Validation and FDA Compliance SME with CSC Government Health Services

Division (November 2009 to Present), Mrs. Skipper prevented significant contract

abatement charges and threat of contract loss through rapid and effective design and

commissioning of a Biomedical Information Technology Quality Management System

merging the medical device, blood and cGMP regulatory requirements with consent decree

requirements and corporate ISO 9001:2008 requirements for CSC’s American Red Cross

program. She successfully deployed a QMS compliant to multiple standards that attained

ISO 9001:2008 registration in Sept. 2010.

She successfully represented CSC as the Biomedical IT Quality Management subject matter

expert during oral presentations for the contract proposal to CareFusion; a potential

customer whose IT infrastructure and applications are regulated as medical devices.

She successfully represented CSC as the Biomedical IT Quality Management subject matter

expert in CSC’s proposal to Gambro Healthcare, a global medical technology company that

supplies products and therapies for kidney and liver dialysis.

She has performed as a subject matter expert advising projects on the installation and

operation qualification requirements for infrastructure transfer from customer locations to

CSC data centers.

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Clinical and Quality Assurance SME with CSC Government Health Services Division DVC

(March 2006 – November 2009), Mrs. Skipper performed as a quality assurance subject

matter expert and auditor for assigned project teams supporting phase 1 through phase 3

bio-defense vaccine studies conducted in the United States and Europe. She assessed

clinical trial proposals and activities, vendor qualification and vendor compliance to

regulatory requirements. She evaluated data transfer specifications, data format

specifications, data management systems and data management processes for suitability

and regulatory compliance.

She served as a key member of bio-surety, bio-safety and risk assessment strategic teams

responsible for feasibility, bio-safety and risk mitigation planning for building a U.S.-based

vaccine manufacturing facility utilizing a whole virus select agent construct.

She worked with the Business Process Operations department to develop and implement

processes, policies and systems supporting improvement in business operations. Examples

are intellectual property identification, assessment and protection; and evaluation of client

requests for incorporation of novel technology into drug development processes.

Quality System Deployment for ISO registration with NuGEN Inc (June 2004 to Oct

2006), Mrs. Skipper performed gap analysis assessments of the quality management system

and facilitated the deployment of an ISO 13485:2003 quality system compliant to FDA

regulations for an analytic reagent manufacturer and supplier to regulated industry. Mrs.

Skipper assisted in the development of standard operating procedures and the quality

manual. Mrs. Skipper retrospectively validated the REES Scientific environmental monitoring

system that was installed in the facility.

As an Associate Director of Quality Assurance with Morphotek, Inc. (February 2004 –

July 2005), Mrs. Skipper commissioned a QSR-based GMP/GLP/GCP compliance and quality

management program for a startup biopharmaceutical company to manage activities

associated with Research and Development, technology transfer, cGMP manufacturing, pre-

clinical development and clinical development of therapeutic recombinant monoclonal

antibody products. She participated on senior management strategic teams supporting

investigational product selection, manufacture and development from R&D stage through

phase I clinical studies. She represented the company externally to regulatory authorities,

business partners, contract research organizations, contract manufacturing organizations,

and by participating on professional committees. She was responsible for product stability

programs and the release/rejection of components, active pharmaceutical ingredient (API),

bulk drug substance (BDS), finished dosage form (FD) and container closure systems.

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