Silas Thomas Email & Phone Number

Parker, Co, Us

Glen Allen, Va, Us

Richmond, Virginia

Responsible for the full scope of quality issues and operational performance related to compliance and quality for blood and stem cell programs and third-party transfusion services. Includes quality/compliance oversight or AABB/CLIA accredited laboratories and FACT accredited HCT/P collection and processing program. • Management of a team of 13 quality professionals• Quality oversight for large geography and multiple facilities across four blood services regions: Pennsylvania, Maryland, District of Columbia, West Virginia, and Virginia (3 manufacturing sites, 5 IRLs, 31 collections sites, 1 stem cell program). • Strategic quality planning and program implementation oversight• Prepare and host internal/external audits• Development and implementation of continuous improvement activities• Guidance and interpretation of regulations/standards (FDA, CLIA, AABB, CAP, FACT)• FACT Quality Manager• Accomplishments: o National team member for One Red Cross – Emergency Action Plan initial implementation and ongoing revisions (developed the Access, Announce, Act method cycle) o Qualifty representative during acquisition of opperations in state of Virginia and ongoing increase in scope of services provided in Virginia (Further manufacturing collections, QC lab, component lab, and Therapeutic Apheresis ) o Serve as a Quality Assurance Lead Develop Program (QALDP) mentor for rising ARC quality professionals. o Team leader for ARC Urgent Health Hazard (UHH) and Material Review Board (MRB) transitions from national headquaters to Field QA.

2825 Emerywood Parkway, Richmond, Va 23294

Responsible for review of the quality systems and compliance in all areas of technical and clinical operations (blood center, stem cell collection, umbilical cord blood collection/processing, and contracted research programs). o Bergen Community Regional Blood Center/NJ Cord Blood Bank/Elie Katz Umbilical Cord Blood – Montvale, NJo Virginia Blood Services – Richmond, VA • Management of a team of four quality professionals • Quality oversight of Blood Bank and Umbilical Cord Blood programs (public, private & third- party processing) • Quality oversight of commercial/clinical contracted research including contract review/approval • Relocated from Colorado to New Jersey to serve as team leader for Quality System Integration at new Vitalant member facility. Prior to onboarding Vitalant performed audit of Montvale activities and identified over 100 observations. Lead the response team to correct all observations within three months. • Accomplishments: o Eliminated unnecessary NJ State registrations/permits resulting in simplified compliance profile o Redesign of multiple quality systems: Document Control, Change Control, and Approved SOP Deviations o Develop contract research approval process bridging local (Montvale, NJ) procedures with Vitalant corporate procedures o Developed validation methods for cord blood processing including processing room validation o Amended contracts and approval process for third party cord blood processing agreements o Led center (Montvale) to first ever FDA inspection with zero findings

Greater Denver Area

Responsible for assisting in the review of quality systems and compliance in all areas of technical and clinical operations. This position serves as a resource to operations on quality issues. • Bonfils Blood Center – Subsidiary of Blood Systems Inc. – Denver, CO• Validation planning, drafting, and review – process and equipment implementation• Root cause and corrective action facilitator• Process improvement coordinator• Internal audit of operational and clinical activities• Review and approval of clinical study and research participation• Accomplishments: o Interim Quality Director - at Bergan Community Blood Services in Montvale, NJ o Traveled throughout the United States implementing BSI/Vitalant Quality Systems process and procedures at sites acquired by BSI o Redesigned product shipping & receiving processes and reduced task time from 3 hours to 30 minutes

Greater Denver Area

Reviewed Post Donation Information-Market Withdrawal events, determined FDA reporting criteria, submitted reports to FDA, created and submitted consignee notifications under the direction of Regulatory Manager. • Facilitated strategy planning and review of standards and regulations: FDA, AABB, CAP & ISO• Organizational cGMP trainer• Label validations• FDA product licensure submission • FDA Establishment registration maintenance • Review/submission of CAP proficiency testing surveys

Denver, Colorado, United States

Master Of Science (M.S.), Health/Health Care Administration/Management

Bs, Biology, Chemistry, Leadership

Activities and Societies: Soccer Team, Resident Assistant, Student Government Association - Humanities/Sciences Representative, Pre-Med.