Marife Samson
Quality & Compliance Leader | GMP Facilities, Utilities, & Equipment
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About
Accomplished Quality Assurance and Compliance leader with 15+ years of pharmaceutical, biotechnology, sterile manufacturing, and cell & gene therapy experience supporting commercial and clinical operations. Recognized for expertise in GMP Quality Systems, Environmental, Facilities, Utilities, Maintenance & Equipment (FUME), Commissioning & Qualification (C&Q), Validation, Deviation Investigations, CAPA, Change Control, Contamination Control, Audit Readiness, and Regulatory Compliance. Proven success partnering with Engineering, Manufacturing, Validation, QC, and Regulatory Affairs to support facility startup, equipment qualification, site readiness, inspection preparedness, and regulatory approvals.
Experience
Quality Supervisor - LONZA HOUSTON INC. - Houston, TX
(2023-06)
- Provide quality oversight of GMP operations supporting cleanroom compliance, environmental monitoring, utility systems including Clean Steam, Process Compressed Air, equipment and associated facility support systems to ensure compliance with cGMP requirements and contamination control programs.
- Utilized MODA environmental monitoring software for data review, trending, and contamination control oversight.
- Managed deviations, investigations, CAPAs, change controls, and risk assessments impacting critical GMP utility systems and manufacturing operations.
- Partnered with Engineering, Facilities, Validation, and Manufacturing teams during startup, qualification, maintenance, and lifecycle management activities for utilities, equipment, and facility systems.
- Supported commissioning, qualification, periodic review, and continued verification activities for critical utility and facility systems.
- Utilized MODA Environmental Monitoring System for environmental monitoring data review, trend analysis and risk assessments to support contamination control strategies investigations, inspection readiness, and quality oversight activities.
- Supported regulatory inspection readiness activities related to facilities, utilities, environmental monitoring programs, equipment qualification, and contamination control systems.
- Participated in cross-functional assessments utilizing TrackWise quality systems for utility excursions and system events to evaluate product impact, determine root cause, implement effective CAPAs, and ensure continued GMP compliance.
- Review and approve SOPs, investigations, technical reports, quality records, and GMP documentation supporting product disposition and batch release.
- Partner with Engineering, Manufacturing, Validation, and QA teams to support facility readiness, startup activities, qualification programs, and regulatory compliance.
- Support internal and external inspections, audit readiness initiatives, and continuous improvement projects.
- Mentor technical staff and foster a culture of quality, compliance, accountability, and operational excellence.
Senior Technical Specialist, QC Microbial Control - LONZA HOUSTON INC. - Houston, TX
(2020-02 - 2023-05)
- Served as SME for contamination control, environmental monitoring, aseptic processing, and microbial control programs supporting cell therapy and viral vector manufacturing. Utilized MODA environmental monitoring software for data review, trending, and contamination control oversight.
- Supported validation, qualification, discrepancy resolution, and risk assessment activities for GMP systems and manufacturing operations.
- Collaborated with QA and Engineering teams to support startup readiness, qualification lifecycle management, and compliance initiatives.
- Participated in investigations, nonconformance management, trend analysis, and CAPA effectiveness reviews.
- Delivered aseptic behavior, gowning, and contamination control training programs.
Senior Microbiologist - QUVA PHARMA - Sugar Land, TX
(2018-05 - 2020-01)
- Supported QA review and approval of validation protocols, GMP documentation, batch records, and investigations.
- Performed sterility, environmental monitoring, and microbiological testing in support of aseptic manufacturing operations. Utilized MODA environmental monitoring software for data review, trending, and contamination control oversight.
- Contributed to audit readiness, deviation management, and quality system improvement initiatives.
- Qualified and trained personnel on aseptic technique, gowning, and contamination control requirements.
Quality Control Technician - ALLERGAN INC. - Houston, TX
(2014-01 - 2018-05)
- Performed microbiological and analytical testing supporting HCT/P products and commercial product release.
- Supported QA-led investigations, CAPA activities, environmental monitoring programs, and GMP compliance initiatives. Utilized MODA environmental monitoring software for data review, trending, and contamination control oversight.
- Conducted technical training and onboarding of laboratory personnel.
- Participated in regulatory inspection preparation and documentation review activities.
Cell Culture / Production Technician - SKINMEDICA / ALLERGAN INC. - Houston, TX
(2007-01 - 2011-05)
- Supported upstream manufacturing and human fibroblast cell culture production within GMP cleanroom environments.
- Assisted with deviation documentation, batch record review, and manufacturing investigations.
- Supported production operations, aseptic processing, and compliance documentation.
Education
Bachelor of Science (B.S.) - Biology - University of Houston
