William Bradshaw Email & Phone Number

Cambridge, Ma, Us

Salt Lake City, Utah, United States

Lead 12-person team responsible for product development and productions Quality System functions, including Training and Document Control, Asset and Facility compliance, Final/In-Process QC, Design and Risk Control, and process verification /validation and improvement. Serve as Quality Management Representative and help to guide other key corporate functions.

Salt Lake City, Utah, United States

Managed ongoing integration of Co-Dx Quality Management System to support legacy tube reagent product lines and future in-development PCR platform. Oversaw CAL/PM, Document Control, Training, MAI (NCR/CAPA, Complaint, Audit) Supplier Management, and Quality support of Environmental Health and Safety (EHS) needs across three facilities.

Salt Lake City, Utah, United States

Working with Director of Quality, developed new from ground-up Quality Management System and numerous operational systems and processes for two biotech start-ups contracted to design, develop, and manufacture a PCR-based in vitro diagnostics instrument with single-use consumables for point-of-care/over-the-counter home use.

Salt Lake City, Utah

Collected, analyzed, and reported on suitability and effectiveness of organization’s Quality Management System (QMS), as manager overseeing Management Review process to support adherence to ISO 13485/9001, FDA 21CFR, MDSAP, IVDD/IVDR, and other jurisdictional requirements. Supported the creation and monitoring of Key Performance Indicators to assess and review QMS and other core Quality functions. • Developed and maintained detailed procedures for all aspects of Management Review process.• Conducted comprehensive analysis and trending of data to assess all required Review Inputs. • Developed Management Review Report and recommendations to consolidate ongoing analysis. • Created formal presentation of analysis and recommended actions to Executive Management. • Defined creation of Quality Objectives as a wholly-integrated process of Management Review. • Worked with QA leaders to standardize collection tools, KPIs, and methodology for future reporting.

Greater Salt Lake City Area

Collaborated across internal functions as manager on Regulatory Affairs and Quality Assurance team to identify compliance gaps and implement process improvements for DNA-based human diagnostic, bio-surveillance, and industrial products.• Led high-profile overhauls of Product Design Control and Software Design Control standard operating procedures.• Co-managed Project with Systems Integration Manager to investigate and mitigate product performance issues. • Collaborated with representatives of parent/sister companies on Quality System changes, and new product proposals. • Assisted core Regulatory activities, including internal/external audits, field actions, and quarterly Management Review.• Completed Exemplar ISO 13485:2016 Lead Auditor Training, August 2019.

Greater Salt Lake City Area

Collaborated across internal functions as member of Product Integration and Transfer team to complete a variety of assignments to implement documented process improvements for DNA-based human diagnostic, bio-surveillance, and industrial products.• Oversaw change implementation to controlled product labels, including interdisciplinary reviews and change orders.• Worked with R&D, manufacturing, quality assurance, and operations teams to create and revise processes, including: - New multi-phase Standard Operating Procedure and approach to product discontinuation and obsolescence- Revised contamination prevention procedure to anchor company-wide health and environmental safety update

Malden, Ma

With System Director, managed $8.4 million annual Community Benefits effort for two-hospital community health system. Served as internal operations lead and external state/federal regulatory liaison. Cultivated relationships and represented hospital system to regional public health and civic leaders, on coalitions, and with other key stakeholders.• Provided financial, contract, and operational oversight for nine hospital departments with total annual budget of $4.5 million, as well as cost and outcomes evaluation for more than 85 community-based health and education activities.• Supervised research consultants and lead development of 2016 Community Health Needs Assessment and 2017-2019 Community Health Implementation Plan, approved by Community Benefit Advisory Council and Board of Trustees.• Co-led volunteer-based partnerships, such as nationally recognized Mobile Food Market, serving 600 families/month.• Provided operations guidance to HHS Lifeline program, achieving 6% year-to-year growth and improved net margins.• Served Malden’s Promise, Tri-City Homeless Task Force, and Mystic Valley Opioid Abuse Prevention Collaborative.

Roxbury, Ma

Managed external relations, fundraising, service contracts, and conducted financial analyses to support Board fiscal oversight, as member of Management Team for Latino-focused human service agency with $3 million annual budget.• Managed marketing activities, including multi-platform social media presence; piloted bilingual social media effort. • Guided proposals to Substance Abuse & Mental Health Services Administration, with $3.6 million in multiyear awards.• Developed strategies to maintain state funding—$300,000 in FY 12 and FY 13 appropriations, and $248,000 in grants.• Planned all fundraising events, including 2011 State House benefit gala that exceeded fundraising targets by 20%. • Represented agency at inter-governmental coalitions, recovery-oriented community events, and other public forums.

Boston, Ma

Oversaw day-to-day operations, including finance, strategic planning, contracting, internal auditing, sales and brand marketing, fundraising, and front of house logistics for award-winning Boston-area Equity theater company.• With Producing and Artistic Directors, conceived and secured rights for four seasons of artistic programming. • Staged more than 250 performances of nine professional productions and a youth education program, produced in three venues, including two 12-week, two-show summer repertory seasons in a historic outdoor amphitheater on the banks of the Charles River.• Contracted and supervised actors, stage crew, and designers; served as liaison to area Equity collective bargaining unit.• With publicist, implemented re-branding strategy, conducted media outreach, and curated content for social media platforms.• Represented company as member of Board of Directors (2009-2011) to state agencies and city arts and cultural groups.

Boston, Ma

Supported activities of 22-member consortium of Boston’s largest arts, cultural and educational institutions located in the Fenway Cultural District, organizing city-wide events, arts promotion, place-making, and environmental advocacy.• Oversaw key parts of Opening Our Doors event, including design, fundraising, day-of-event logistics, promotion, and evaluation.• Supported Alliance operations in the areas of budget management, accounting and cash management, and audit functions.• Represented Alliance on community coalitions and groups, such as the Muddy River Restoration Project, as a member of the Emerald Necklace Board of Overseers, and on behalf of the Alliance to city and state agencies and community groups.• Participated in full-year strategic planning process to develop new strategic goals and operating structure for the Alliance.• Managed web site, including major re-design and pilot of new comprehensive Cultural District-wide events calendar.

Greater Boston Area

Advanced fundraising, community engagement, marketing, and preservation efforts as member of senior management team for urban visual and performing arts center, including landmark Cyclorama event venue, in Boston's South End.• Managed strategies to meet and achieve BCA annual fundraising goals of $500,000-$600,000 in 2005 and 2006.• Collaborated with COO to contain expenditures and realize consecutive operational surpluses during two fiscal years.• Oversaw two gala events, including BCA 35th Anniversary celebration, netting more than $200,000 to exceed fundraising goals. • Organized logistics for the BCA portion of the Calderwood Pavilion at the Boston Center for the Arts Grand Opening.• Wrote all grant/sponsorship proposals and obtained more than $800,000 in capacity building and capital grants. • Developed strategies related to stewardship of individual donors, including donor events, solicitations and prospecting.• Managed redevelopment of donor database systems to support long-term strategic growth in fundraising.• Oversaw marketing, branding, and public relations functions for the Center and affiliated cultural activities.• Supervised two staff members, and managed development, marketing, and event budgets.• Worked closely with 30-member Board of Directors and actively staffed 70-member Board of Visitors.

Lawrence, Ma

Managed and guided key aspects of $10 million Capital Campaign for construction of new Emergency Department.• Provided one-on-one support to CEO and 20-member Campaign Cabinet, including donor meetings and cultivation events.• Designed custom prospecting system to target and track donor solicitations and donors for acquisition into annual giving program.• Developed grant proposals raising more than $300,000 in project-specific funds, including matching gifts.

Lynn, Massachusetts

Coordinated marketing and fundraising efforts for visiting nurse association and its private home care division.• Provided logistical support for fundraising events, created first ever Annual Appeal, and oversaw Flu Clinics at 35 area sites.

Lawrence, Ma

Served as member of three-person Public Affairs department for 182-bed regional hospital Northwest of Boston.• Wrote multiple grant proposals securing more than $168,000 in funding, and supported full range of PR and marketing functions.

Malden, Ma

Served as primary local media contact and marketing specialist for 3-hospital health system North of Boston.

Master Of Business Administration - Mba, Business Administration And Management, General, 3.97

Master'S Degree, Health/Health Care Administration/Management, 3.98

B.S., Communication, Magna Cum Laude