Jessie A.

About Jessie A.

Hematology, Blood Bank, Chemistry, Immunology, Special Chemistry, BioChemistry…

Experience

1. Director of Quality - Regenerative Medicine (Clinical Clia Ops Quality)

   Histogen

   Nov 2021 — Present

   I successfully managed and led a Quality team, with a primary focus on team-building and driving improvements. I took charge of an Audit of a CMO facility and developed a Quality Management System (QMS) program from scratch to establish a cGMP environment. My duties involved reviewing internal and external data and records, providing oversight and support for site operations, and collaborating closely with management and cross-functional leaders on projects and operational decisions. KEY ACCOMPLISHMENTS: • Provide oversight and leadership to the Quality Assurance, Quality Systems and Compliance, Laboratory Services, Regulatory, and Continuous Improvement teams, including hiring, managing, motivating, coaching, mentoring, and defining and oversight of implementation and maintenance of the Quality Management System. Ensure the facility is inspection and audit ready and support regulatory inspection and third-party audit program • Participation as a core member of the Operations Leadership Team, which is responsible for operational oversight of all company operations, and as a core member of the Executive Team, providing strategic guidance related to quality within the overall organization. Provide reports on the quality organization to the ownership and/or Board of Directors • Development of corporate quality objectives and linking them to meaningful and measurable quality metrics which are aligned with corporate objectives • Identify opportunities/risks and propose methods to improve the quality of customer products, services being administered, department operations, and/or costs. • Provide opportunities to improve company products, and Zinances and Zind ways to reduce costs but still have high-quality services • Provide Purpose, Direction, Engagement, Recognition, Empowerment, Enhancement of Skills and Knowledge, and Understand Processes to Optimize Performance

Education

• Scilife, Madrid, Spain

  Compliance Business Advantage in Healthcare Technology, ANNEX I, GLP Compliance

• Harvard Medical School

  Accreditation Council for Continuing Education, Medical (ACCME)

• University of Pangasinan

  B.S, Medical Technology

• Cabot Colleges

  Phlebotomy Technician/Phlebotomist

• Florida Metropolitan University

  MBA, International Business

• System Technology Institute

  Computer Programming