William Bishop 862.266.1301 | wjbishop@gmail.com | LinkedIn

PROJECT MANAGER & PROGRAM ANALYST Project & Program Manager with Proven Experience Driving Consistency and

Cost Effectiveness in Large-Scale Initiatives through Team & Regulatory Affairs Leadership

Project P lanning & Def in it ion ● Process Improvement ● Team Leadersh ip ● Audi ts & Regulatory Affa irs

Highly Accomplished Project Manager – Brings a high-level of effectiveness managing various programs and initiatives within the public sector with a strong emphasis on regulatory affairs. Continually drives programs to success through team leadership, coaching, management and deployment, ensuring alignment between all resources and project requirements. Maximizes efficiency and quality through program analysis, ensuring 100% compliance with all policies, procedures, and regulations.

EXECUTIVE ASSETS

■■ Regulatory Affairs Operations ■■ Continuous Process Improvement ■■ Cross-Functional Collaboration ■■ Program Analysis & Monitoring ■■ Establishing Project Requirements ■■ Team Leadership & Management ■■ Quality Assurance / Control ■■ Key Performance Indicators (KPI) ■■ Coaching / Training / Mentoring ■■ Strategic Planning & Execution ■■ Internal & External Communication ■■ Complex Project Management

PROFESSIONAL EXPERIENCE

Food and Drug Administration (FDA) | San Diego, CA 2/2011 - Present Consumer Safety Officer Conduct regulatory inspections and in-depth investigations of facilities, serving as Lead Agency Representative of multi-agency and multi-organization investigations. Actively monitor and support compliance programs for sample collection and inspection programs. Provide strategic recommendations and guidance regarding complex regulations, legislation, and administrative procedures. Perform in-depth analysis of investigation results, preparing proposals and final endorsements.

o Take the lead on high-level investigations involving incidents resulting in injury or death attributable to products

regulated by the Food and Drug Administration (FDA).

o Saved approximately $5,000 annually by developing, planning and overseeing an initiative to reduce the generation of

UPS shipping labels and the use of shipping materials, lowering monthly shipping expenses.

o Accountable for how investigations should proceed, when an investigation is complete, and what reporting is required.

o Serve as an Instructor providing training to peers, as well as State and Local Government personnel, on sophisticated

techniques employed in establishment inspections and investigations.

o Review and evaluate scientific data encompassing a full suite of manufacturing processes related to new drugs, food

additive and medical devices, as well as other manufactured products.

o Develop and present high-impact presentations, workshops and seminars on complex scientific and technical data.

o Increased collections 20% per month by developing a system that increased efficiency with the allocation of resources.

o Quelled an outbreak of Salmonella Agona that posed a significant public health risk by sampling more papaya entries

than any other investigator during the inspection period.

PHARMACEUTICAL EXPERIENCE

Additional experience in the pharma sector as an Intern with TUFTS New England Medical Center, as well as with Brooks Eckerd Pharmacy. Ensured 100% compliance with all internal policies and procedures, as well as with external guidelines and regulations. Leveraged a strong working knowledge of pharma, including tech, compliance, auditing and Federal regulations.

EDUCATION & TRAINING

Bachelor of Science (BS) in Health Sciences, Minor in Chemistry, University of Arizona, 2010 Doctor of Pharmacy Program, Northeastern University (Partial Completion)

Advanced Training in Evidence Development, ORA Personal Safety, and Food & Drug Laws