Michael Dragone Email & Phone Number

Boston, Ma, Us

Manage daily operations of Albireo quality systems. Manage quality events and processes (deviation, change control, etc.) and review board activities. Support quality metric reporting and periodic assessment of health of Albireo quality systems.• Support process and technology initiatives for Albireo quality systems and participate in continuous improvement projects including automating Quality processes which streamlined the Quality space.• Author and maintain procedures supporting quality systems maintaining compliance with regulations and Albireo policies.• Implemented Albireo electronic document management system to identify, communicate, and mitigate quality risks in a proactive and collaborative manner.

Project Manager and System Administrator for implementation and use of SOLABS QM 10 core system including Change Control, Deviations and CAPA sections. Acted as primary Quality liaison to business for planned application development, system implementation and integration projects. Managed all Quality Systems consultants and activities.• Managed document migration into new SOLABS QM 10 system which improved the safety and ease of use for all regulated departments.• Partnered with business stakeholders and vendors to define project scope, objectives and business requirements, deliverables, which included the roles for all regulated departments.

Newton, Ma, Us

Owned and managed all aspects of key quality systems including but not limited to eDMS/CMS (Veeva Vault), Please Review, Right Find, Regulatory Intelligence, Clinical Trial Management System (CTMS) and related validated environments. As primary liaison to the business for planned application development, system implementation and integration projects, partnered with business stakeholders and contributors to define project scope, objectives and business requirements, deliverables, and timelines for new projects.• Partnered with internal project team members in selection, development, testing, validation, training, implementation, and ongoing support of business systems.• Managed development, authoring and implementation of SOPs for new system implementations and system updates.

Newton, Ma, Us

Supported evaluation, selection, and implementation of systems for R&D functional areas. Managed various R&D and company-wide system initiatives including internal negotiation efforts for SOWs, service agreements, licensing costs and general support. Served as system administrator for multiple applications and functional stakeholders including Veeva Vault, Please Review and Clinical Trial Management System etc.• Developed, implemented and innovated business processes to promote operational and cost effectiveness among functional groups.• Partnered with internal stakeholders to lead validation efforts for new and existing systems to maintain compliance according to 21 CFR Part 11 and Annex 11.

-Worked with various management teams and staff to develop work goals based on stated corporate goals for a large corporation-Developed curriculum outlines for adult learning theory and course development-Consulted on training solutions to mitigate batch record review in a GxP environment

Boston, Ma, Us

Managed all aspects of the On-the-Job training program company-wide and senior contributor to Training function within Quality Systems group. Reviewed qualifications, interviewed and hired interns within Quality Systems. Acted as Business Administrator for the Learning Management System (LMS) (Compliance Wire). Managed GMP groups to implement process improvement of the Training function.• Developed, updated and presented GMP and Vertex-specific training for company training programs.• Partnered with various cross-functional groups companywide to ensure training needs were complete and compliant for the GMP regulated organization.

Boston, Ma, Us

Senior contributor to the Training function within the Quality Systems group. Acted as point of contact for Learning Management System (Plateau) questions, upgrades, and enhancements. Acted as mentor for Quality training staff as well as departmental training coordinators. • Implemented GxP and Vertex-specific training which addressed and improved training compliance for all regulated departments.• Developed and facilitated a variety of training courses including Train-the-Trainer, On-the-Job training, and Writing Effective Skill Assessments programs.

Thousand Oaks, Ca, Us

Managed training activities which supported Quality Analytical Laboratories, Manufacturing and Finance. Developed and executed training curricula for all areas of client groups. Designed and delivered effective classroom, one-on-one and on-the-job training. Facilitated programs in Analytical Change Control, Meeting Effectiveness, Front Line Manager training,• Coached and developed Subject Matter Experts and certified trainers within client areas.• Partnered with client groups in work environment to understand and assess specific training needs.• Inspection Awareness, and Basic Skills for Manufacturing.

Washington, Dc, Us

Ensured compliance with all applicable local and national procedures, policies, and directives. Managed a staff of 5-9 supervisors, trainers, and compliance specialists.• Received and reviewed all new policies and procedures and develop implementation plans together with the Product Management team.

Bachelor’S Degree, Medical Laboratory Science

Master Of Science, Training And Development

Bachelor’S Degree, Health Science

Doctor Of Philosophy - Phd, Human Development And Behavior