Mariel D. B.

About Mariel D. B.

Quality Leader who uses a collaborative approach to activate, implement, and deliver essential, value-added solutions to Life Sciences industries in the pursuit of life-saving medicines.~Over twenty years of progressive experience in drug substance and drug product manufacturing (biologics, vaccines, and small molecules), engineering, validation, and quality management systems.~Over ten years in leadership roles including developing, training, coaching, and mentoring direct reports and quality professionals.~Subject matter expert (SME) in Computer Validation, Equipment Qualification, Quality Management Systems (QMS), Regulatory Compliance, Auditing, Organizational Excellence, and Project Management.~Extensive experience driving process improvement, change management, and innovation. Expert knowledge in resolving complex situations of scientific and regulatory nature.~Hold certifications from the American Society for Quality (ASQ) for Quality Engineer (CQE), Quality Auditor (CQA), and Manager of Quality and Operational Excellence (CMQ/OE).

Experience

1. Manager, Equipment Validation

   United Therapeutics Corporation

   Nov 2019 — Present · Silver Spring, MD, US

   Lead Silver Spring site validation activities related to equipment, computer systems, and associated automation systems per validation master plans. Perform data integrity and electronic record and signature assessments. • Effectively plan and communicate Validation Project Schedule, and report monthly project and document status to senior management across departments.• Staff supervision (4 direct reports and contractors as needed) including recruiting, setting priorities, developing staff, and performance management. • Oversee and review technical data generated during validation execution to ensure accurate conclusions. Reviews and approves validation and qualification reports for adequacy, completeness, and compliance with UT procedures and regulatory requirements.• Review and approve change controls and validation assessments in TrackWise.• Major Accomplishments- Major upgrade qualifications for Biologics, Fill Finish manufacturing areas, and QC laboratory equipment for aging equipment- Successfully supported regulatory audits in 2024, with direct contact representing Validation and answering auditor’s questions including validation strategy defense and audit responses- Upgrade and Qualification of the Validation Test Equipment – ELLAB Software Windows 11 upgradeand Kaye Validator AVS Tablet Upgrades were procured, connected to the network, and qualified in 2024. These upgrades renovated test equipment and continue increasing the data integrity of our operations- Coordinated and executed the Security Patching Project with the Operational Technology, Information Technology, and Quality Control teams to ensure the most critical QC instruments (11 units) had backup and patching software installed and qualified with no impact on the QC testing schedule.

Education

• University of Maryland Global Campus

  Master of Business Administration - MBA, Business Administration, Management and Operations

• Montgomery College

  ICF Coaching Certification Program

  2019 — 2020

• University of Puerto Rico-Mayaguez

  Bachelor's degree, Chemical Engineering

Skills

• Root Cause Analysis
• Sterilization
• Purification
• Glp
• Internal Audit
• Quality Control
• Gmp
• Change Control
• Laboratory
• Biopharmaceuticals
• 21 Cfr Part 11
• Lims
• Cleaning Validation
• Six Sigma
• Gxp
• Equipment Qualification
• Quality Auditing
• Aseptic Processing
• Standard Operating Procedure (Sop)
• Biotechnology
• Fermentation
• Continuous Improvement
• Laboratory Information Management System (Lims)
• Technology Transfer
• Quality System
• V&V
• Vaccines
• Corrective and Preventive Action (Capa)
• Aseptic Technique
• Validation
• Iso 13485
• Quality Assurance
• Trackwise
• Iso
• Medical Devices
• Capa
• Pharmaceutical Industry
• Sop
• Gamp
• Fda