TrackWise
Billy Josay, MBA
IT Project/Program Manager
Washington,PA
Summary
My experience in Laboratory, Quality Operations, IT, and Project Management spanning multiple GxP global environments has allowed me to continuously excel for more than 18 years. I have a strong analytical mindset and have excelled in high-stress situations; including supervisory and leadership capacities, to meet and exceed company objectives. I am a motivated, driven person who exemplifies strong work ethic and core values, unrelenting in pursuit of peak results.
Overview
6
6
years of post-secondary education
18
18
years of professional experience
Work History
IT Project Manager
Mylan Inc.
Canonsburg, PA
2016.03 - Current
- Managed large portfolio of multi-phase projects for the company's global Quality Management Systems platform in excess of $10M annually. Reported progress and influence positive outcomes for key stakeholders.
- Delivered solutions below the allocated budget - closed more than 50% of projects (since 2015) 5%-10% below budget.
- Managed a team of 8 Software Engineers/Developers as both internal and external direct reports.
- Served as the main interface between IT resources, executive management, and business sponsors within the company's Quality Management Systems portfolio.
- Ensured proper compliance and SDLC methodology.
- Addressed key initiatives within the company's portfolio, in the current fiscal year and in leading crucial planning sessions for future year roadmaps.
- Authored and reviewed critical documents requiring both internal stewardship and ensuring GxP compliance; including all standard project lifecycle deliverables.
- Presented projects before company leadership. Organized and lead weekly meetings and conference calls with members from business, IT, and third-party vendors to identify project status, action items, hindrances, and project planning to facilitate successful delivery.
- Monitored contracts and service level agreements to identify potential risks and implement mitigation actions to protect development process from unforeseen delays and costs.
Lead Business Analyst
Mylan Inc.
Canonsburg, PA
2014.09 - 2016.03
- Gathered Requirements for individual Quality Management Systems projects based on interfacing with Business Leads, Business System Analysts (BSA), IT Solution Leads, and other key stakeholders to determine best-fit solutions for individualized projects.
- Collaborated with internal/external software and hardware designers during solution development.
- Facilitated solution implementation based on compliance, user accessibility, effort estimation, resource management, and financial constraints.
- Authored, Reviewed, and Approved Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Ensured Compliance through monitoring/evaluation of existing business processes, systems, and industry trends.
- Generated Metrics and other Key Performance Indicators (KPI's) on weekly, bi-monthly, monthly, and quarterly basis for senior management.
Application Specialist
Mylan Inc.
Morgantown, WV
2012.03 - 2014.09
- Compiled, indexed, archived, and presented monthly/quarterly metrics reports to management for multiple projects within TrackWise Quality Management System.
- Monitored system usage and user compliance within application.
- Assigned Lead Analyst role in processing primary review for TrackWise Change Control systems, performed supporting roles in closure of Change Control records, troubleshooting technical aspects, and system querying, reporting, and exporting data throughout document life cycle.
- Maintained control of document routing, risk trending, and facilitated timely reviews and approvals.
- Authored, tested, and approved IQ/OQ/PQ validation in Mylan Testing Center (MTC) for multiple workflow projects within TrackWise Quality Management System (Change Control, Complaints, Investigations, CAPA, Audit, etc.).
- Provided workflow training, system training, and project lifecycle training for employees with new/additional access to TrackWise application.
- Compiled, indexed, and archived Annual Product Reviews for Remediation Plans and other due diligence projects, as necessary.
- Processed records in conjunction with Supply Network Committee (SNC) to ensure appropriate parties were notified and remained compliant.
Senior Quality Assurance Analyst
Mylan Inc.
Morgantown, WV
2007.03 - 2012.03
- Reviewed experiments, instrumentation, support data, and reports for method validations and biostudies to US and International regulatory agencies for compliance, correctness, scientific integrity, and consistency.
- Performed in-process field audits in addition to write, edit, and review audit reports for method validations, biostudies, and instrument systems.
- Authored, reviewed, and approved SOPs, Guidelines, and Observation Reports; performed Quality Review of Event/Investigation Reports for compliance, scientific integrity, and impact assessment.
- Maintained Observation Tracking Binder detailing all observations issued within the Bioanalytical Laboratory; conducted semi-annual impact assessment reviews with senior laboratory management.
- Performed final review and approval of Representative Chromatography, Abbreviated Study Reports, Method Validation Reports, and Biostudy Reports within Documentum system for electronic submissions.
- Served as a liaison between Bioanalytical Laboratory, Pharmacokinetics Department, and Regulatory Affairs departments to efficiently communicate issues and expediently meet deadlines.
Quality Assurance Analyst
Mylan Inc.
Morgantown, WV
2006.03 - 2007.03
- Audited biostudy and method validation reports prior to submission to the FDA.
- Directed numerous presentations and assisted team-oriented meetings with management.
- Tracked/Trended report deadlines and release dates for Quality Assurance Unit.
- Developed efficient inventory system for indexing, archiving, and other long-term storage.
Analytical Chemist
Mylan Inc.
Morgantown, WV
2002.11 - 2006.03
- Performed sample dispensing and extraction procedures for bioequivalence (BE) studies and method validation; assisted in method development, and authored computer programs for various instruments.
- Performed daily maintenance and calibration on bioequivalency instruments, executed biostudy and method validation experiments using Waters HPLC systems and Thermo LC/MS systems.
Education
Certificate of Project Management -
2016.11 - 2017.02
- Continuing Education in Project Management
- Graduated with 3.9 GPA
MBA - Organizational Leadership
2004.08 - 2006.05
- Graduated with 3.8 GPA
- Graduated in Top 5% of Class
Bachelor of Science - Chemistry
1998.08 - 2002.05
- Awarded John Husher Science & Technology Scholarship
- Majored in Chemistry and Fine Art
- Elected Vice President Interfraternity Council 2001
- Elected Vice President Kappa Sigma Fraternity 2001
- Member of Varsity Baseball Team 1999-2002
Skills
Project Management
Program ManagementProject Management Body of Knowledge (PMBOK)Business AnalysisSAP ImplementationIT Service ManagementSoftware Development Life Cycle (SDLC)Change ManagementDeliveryIQOQPQQuality AssuranceQuality ManagementValidationWaterfall methodology
Reporting template development
Risk mitigation planning
Documentation Management
MS Office
Microsoft Excel, Project and Visio
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Software
Documentum
ServiceNow
MiniTab
Snag-It
SAP
LIMS
ALM
Timeline
University Of Miami - Certificate of Project Management,
2016.11 - 2017.02
IT Project Manager - Mylan Inc.
2016.03 - Current
Lead Business Analyst - Mylan Inc.
2014.09 - 2016.03
Application Specialist - Mylan Inc.
2012.03 - 2014.09
Senior Quality Assurance Analyst - Mylan Inc.
2007.03 - 2012.03
Quality Assurance Analyst - Mylan Inc.
2006.03 - 2007.03
West Virginia University - MBA, Organizational Leadership
2004.08 - 2006.05
Analytical Chemist - Mylan Inc.
2002.11 - 2006.03
Washington & Jefferson College - Bachelor of Science, Chemistry
1998.08 - 2002.05