Project Manager Quality Assurance

Pattie Skeens

** ******** **** *****, *** London, CT

860-***-****, **************@*****.***

Key Strengths

Quality assurance, compliance/inspection readiness, system/software development life cycles, computer system validation, process improvement/engineering; process implementation; internal/external auditing (eg, computer systems, investigator sites, vendors, processes and documents), gap analysis/risk assessments, root cause analyses, and mentoring/training.

Knowledge of global regulatory requirements, especially ICH/GCPs and 21 CFR Part 11.

Excellent interpersonal, organizational, planning, implementation, follow-up, written and oral communication, presentation, facilitation, influencing/collaboration, innovation, management, project management, problem solving/decision making, negotiation, team-work, and listening skills.

Professional Experience

Pfizer, Inc., Groton/New London, CT July 1994 to March 2012

Clinical Quality Lead (CQL) March 2010 – March 2012

• For Phase I/Proof-of-Concept/Phase IV studies, instilled concepts of Quality Management and Inspection Readiness, ensured clinical trial project work was conducted to global regulatory standards and internal requirements and could withstand regulatory inspections and ensure subject safety and data integrity.

Participated in all internal/external (global regulatory agencies) audits: received initial notifications, reviewed audit plan requirements with study teams, coordinated resources, gathered required documentation, assisted study teams as needed, attended opening/closing meetings, reviewed all audit reports, monitored corrective action/preventive actions related to audit observations and ensured action implementation/closure.

Evaluated/reported on trending from audit findings and implemented any associated corrective actions

Worked with Regulatory QA representative to schedule site/vendor/process audits.

Member of various cross-functional teams (eg, worldwide regulatory, legal, global clinical trial management, contracts and outsourcing, clinical quality management, SOPs, etc.) to harmonize compliance goals/processes.

Evaluated compliance risks and implemented corrective actions.

• Involved in ensuring quality/compliance related to many aspects of the drug development process, for example:

Standard Operating Procedures/process design

Trial Master File QC design/implementation

Clinical Study Registry Database QC design/implementation

Computer system/data migrations

Metrics/Clinical Quality Assessments

Audits and Inspection Readiness

CRO/Vendor Oversight

Clinical study targeted reviews of various clinical trial processes

Training Compliance

Job Descriptions/CVs/Organization Charts

Trained staff on various aspects of inspection readiness.

Reviewed new/updated SOPs.

Worked with Information Technology representatives to automate various inspection readiness tools, to design automated Trial Master File and Registry QC tools, wrote associated guidance documentation, and developed/presented training slides.

Worked with clinical study teams across therapeutic areas to ensure compliance at key compliance milestones during study start/study conduct/study close.

Experience with quality management plans/audit inspection plans/business continuity plans.

• Developed various metrics reports and performed various quality control assessments of processes and systems.

Performed risk assessments/gap analyses, root cause analyses, evaluated lessons learned and implemented process improvements.

Evaluated and updated current training curricula as needed, developed/delivered various training sessions, and developed onboarding and “quick hits” training sessions for new hires.

Responded to GCP-related questions daily regarding study startup/study conduct/study close

Managed contractor resource.

Clinical Statistical Programmer November 2007 – March 2010

Member of various study teams across therapeutic areas, accountable for programming activities to support clinical trial submission deliverables.

Provided input to programming resource planning and report progress, issues, key activities.

Provided standard and non-standard data sets, tables, listings, figures required for Phase I clinical study reports.

Wrote the Study Programming Plan, the Data Review and Planning document, the List of Tables and the Table Shells for each study.

Provided support for specified additional data analyses (eg, interim analyses).

Collaborated with project team members across therapeutic areas, especially the clinical project managers, statisticians and clinicians.

Provided contractor oversight, ensuring understanding of programming requirements, resolution of issues, constant communications of project updates, and compliance.

Participated in company-sponsored Science and Math Jamboree for area eighth graders.

Worldwide Regulatory Affairs Auditor/Business Manager for the September 2003 to November 2007

Regulatory Worldwide Audit Management and Metrics System

Auditor

GCP auditor performing investigator site, computer system, process, vendor, and document audits.

Reported to upper management as needed for any critical audit findings and invoked key players (eg, legal, contracts and outsourcing, regulatory, etc.) to analyze/proceed with steps forward to correct the issues.

Trained on GLP audit practices and shadowed on some GLP audits.

Trained on Pharmacovigilence audit practices.

Regulatory quality assurance representative on various study teams across therapeutic areas for Phase II/III studies, providing guidance on the resolution of GCP issues.

Designed various audit tools to increase efficiency/compliance and reduce time/cost.

Reviewed various quality standard operating procedures.

Developed computerized system checklist for monitors, facilitated pilot and subsequent implementation of checklist to ensure investigator site compliance with 21 CFR Part 11.

Assisted during various FDA/MHRA audits.

Evaluated/reported on trending from audit findings and implemented any associated corrective actions.

Facilitated the Connecticut GCP team, consisting of various pharmaceutical/biotech companies that met monthly to share quality/compliance issues/resolutions.

Member of the Software Quality Assurance Society.

Coordinated/facilitated monthly Auditor Forum meetings.

Participated in company-sponsored Science and Math Jamboree for area eight graders.

Participated in United Way Campaign.

IT Business Manager – Regulatory Worldwide Audit Management and Metrics System

Managed the development, testing and implementation of three major releases of the Worldwide Audit Management and Metrics System (WAMMS).

Gathered user requirements; wrote business documentation as required for the current software development life cycle process (eg, 21 CFR Part 11 risk assessment, user/functional requirements, test scripts, user guide, training, release notes, etc.)

Reviewed all technical documentation (eg, project plan, system requirements/design, traceability matrix, disaster recovery plan, etc.).

Ensured system validation process was completed for each release..

Set up/facilitated global user acceptance testing of each major release.

Determined budgets for each new release.

Ensured system met all internal security requirements for servers/access.

Developed and delivered training for global users; developed presentations and performed demos as needed.

Managed move of database between servers and implemented issue resolutions that saved the company $1.5 million by preventing ‘forklifting’ of servers.

Process Engineer May 2001 – September 2003

• As a member of the Process Development (PD) Global Committee, assisted in the writing of the PD Founding Principles Document that described mission, roles/responsibilities, customers/partners, skills required, etc.

• Developed the PD Methodology and associated Toolkit used by the group globally.

• Led the core cross-functional teams in the successful re-engineering of the following initiatives to shorten timelines, improve efficiency, decrease cost and maintain quality. This included developing the strategy, performing impact analyses, designing process maps and developing associated documentation. Wrote communications/ implementation plans and developed/delivered training.

• Fast Reporting process to achieve final Clinical Study Report to within 4 weeks of database release.

• Database lock within 2 weeks of last subject/last visit.

• Globalized randomization process.

• Pre-filing and filing packages.

• Informed Consent process for Phase II/III studies.

• Generation of statistical analysis plan and the generation of draft/final tables for regulatory submission.

• Provided support to various function groups to identify issues within the group’s organization, identified various gaps, performed root cause analyses, and defined/monitored actions to mitigate gaps.

• Reviewed the Optimizing Process Design system, which was created to hold the company’s processes, templates, and guidances related to the full clinical trial life cycle.

• Worked on the analysis for a single global analysis and reporting system. Conducted two rounds of interviews with stakeholders including Clinicians, Statisticians, Medical Writers, StAR personnel, data managers, etc. Provided input into documentation summarizing the stakeholder analyses.

• Set up the group’s project areas in Livelink and wrote the Livelink Standards and the Usage of Livelink/Insight Guidelines documents.

• Key player in implementing the PFISH reward program.

• Chairperson of the People Services Serving Together (PSST) poster session, showcasing the talent/responsibilities/ successes of each department within the company.

Lead Computer Validation Specialist, Software Quality Management September 1997 – April 2001

With my supervisor, defined/developed the local validation group/SOPs/processes/templates/etc., and eventually supported the development of the validation groups in the UK and Japan.

Developed the Validation Methodology and associated Toolkit used globally, including the Validation SOPs and associated work instructions.

Worked in conjunction with the IT group to ensure validation SOPs/work instructions were harmonized with IT software development life cycle SOPs/processes.

Coordinated/managed activities related to computerized systems validation, both local and global, to ensure quality was built into IT systems and that systems were designed, developed, and implemented in compliance with global regulatory agency guidelines (GCPs, 21 CFR Part 11, etc.) and Pfizer requirements.

Wrote validation plans (including risk assessments), reports, maintenance agreements, etc. Reviewed all validation documentation sets (project plans, business deployment plans, software design documents, training guides, user acceptance test documents, etc.) written for each of these systems to ensure compliance with global regulatory agency requirements.

Wrote user acceptance test scripts as needed.

Coordinated support resources and user acceptance testing and other software and systems implementation activities.

Audited sites, vendors and software suppliers (eg, facilities, organization/personnel, contracts/agreements, operating procedures, training, system validation, computer security, and database integrity).

Continuous awareness of new regulatory agency regulations, evaluation of the impact of regulations on computer systems, and implementation of any corrective actions needed to maintain compliance.

Led the implementation of 21 CFR Part 11. Developed the first Part 11 checklist used in analysis of computer systems. Member of the Corporate Electronic Records and Electronic Signatures (ERES) Committee that developed guidances and training on Part 11 globally.

Took the first fully electronic record/electronic signature system through the validation process as related to 21 CFR Part 11. Presented at a PERI conference in Washington D.C. on the hurdles/successes in implementing a fully electronic system in relation to 21 CFR Part 11.

Managed a small group of employees – met weekly to review project status, issues, resolutions, etc. Reviewed/commented on all validation plans/reports and other documentation as requested, and trained group members as needed..

Developed/delivered presentations on various aspects of validation as requested.

Took Japanese language and writing lessons to support development of a validation group in Japan.

Participated in company-sponsored Science and Math Jamboree for area eight graders.

Participated in United Way Campaign.

Administrative Assistant, Biometrics July 1994 – August 1997

• Provided administrative support to the Group Director, Biometrics, and the Biometrics group.

• Maintained spreadsheets for travel/expenses, protocols, action items, transmittal sheets, seminars/

conferences/training, and resumes.

• Coordinated input to and distribution of the Biometrics Quarterly Plans.

• System administrator of a Lotus Notes database.

• Provided liaison/support to Biometrics New York/Sandwich/Japan and contractors supporting

Biometrics efforts.

• Presented at each Biometrics Communications Meetings regarding administrative issues.

• Assisted in compiling budget input relating to travel/expenses within Biometrics.

• Set up all candidate interviews; interviewed prospective secretaries/secretarial temps, and supervised

secretarial temps.

• Key player on committee to resolve space issues – implemented hostelling and flex place working initiatives.

Analysis & Technology (Naval Contracting Company) May 1980 – May 1994

Analyst/Project Manager working on-site at the Naval Submarine Base, Groton, CT, and at the Naval Undersea Warfare Center in New London, CT

• Project Manager for Weapons System Program – planned /coordinated all designated tasks to ensure goals/ timelines/cost were met.

• Performed research and development for submarine exercise scenarios, evaluating proposed employment guidance and equipment changes to improve weapon performance.

• Performed analyses on data from submarine exercises and wrote various technical reports regarding various submarine systems, modifications to these system, and risk assessments.

• Wrote various weapon-related programs in FORTRAN.

• Wrote diagnostic software procedures and tactical interfaces for surface ship sonar systems.

• Led all tours/demos/presentations of the various sonar systems within the Land-Based Integrated

Test Site at the Naval Underwater Systems Center for all visiting dignitaries.

• Chairperson of the QA/QC Committee.

• Maintained, troubleshot, and installed hardware and software as required on various PC and MacIntosh computers. Installed a LAN network system to connect various PCs.

• Worked with ORACLE databases, writing various SQLPLUS programs to generate reports.

• Managed small group working on various naval contracts.

Education

1975 - 1977 Southern Connecticut State University 2000 University of New Haven/Charter Oak College

Oceanography B.S. in Computer Science

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