Miguel Angel C.
Quality Management in Cell & Gene Therapy Manufacturing | Cross-functional Process Improvement
- Role
- Senior Quality Assurance Specialist - Qms at Lonza
- Location
- Houston, TX, US
- LinkedIn followers
- 500 followers
About Miguel Angel C.
Lifelong learner motivated by continuous improvement, quality management, and cross-functional collaboration.Passionate about fostering and enabling the optimal use of knowledge and information resources in organizations, with a special interest in facilitating effective cross-funcional collaboration and adoption of lean processes, to drive efficiency, synergy and continuous improvement, with a focus on quality management & compliance.My professional experience weaves a synergistic set of competencies and tools in quality management, scientific R&D operations, technology transfer & commercialization, program project management, strategy & planning, technical and business communications, etc. My experience is primarily in fields involving biopharmaceutical manufacturing operations and biomedical R&D, related to clinical translation (development and commercialization of technologies with biomedical utility).If you wish to connect but we have not interacted previously, please include with your request a message explaining briefly why you wish to connect. Thank you!
Experience
Senior Quality Assurance Specialist - Qms
Sep 2025 — Present · Houston, TX, US
Host for the site\'s quality review board meetings, including Deviation Review Board, Change Review Board, and CAPA Review Board, serving as organizer, facilitator, and as QMS SME (as needed).Local administrator & superuser of the QMS, managing user access and assisting with special interventions in record workflows.Instructor and curriculum coordinator for QMS user courses at site.Champion for compliance & continuous improvement, actively promoting a culture of quality balanced with operational delivery, through facilitation of quality risk assessments, coaching, and various quality assurance services, leveraging versatile & extensive experience in manufacturing and ancillary operations within cell & gene therapy and other specialized modalities of biopharmaceutical technologies.Maintain metrics for quality record management & trending, monitoring KPIs and communicating insights to leaders & other stakeholders.
Education
Rice Business
Certificate, Life Science Entrepreneurship
University of St. Thomas (TX)
Graduate coursework - Clinical Translation Management, Business, Management, Marketing, and Related Support Services
Texas A&M University
Graduate-level coursework & research - Chemistry
Universidad de Guadalajara
Licenciatura, Chemistry
Blinn College
Certificate, Science education
Texas A&M University
Master of Biotechnology, Biotechnology
Mays Business School - Texas A&M University
Certificate, Business, Management, Marketing, and Related Support Services
Skills
- Molecular Biology
- Document Management
- Materials Science
- Biologics
- Organic Synthesis
- Nanotechnology
- Lifesciences
- Uv/Vis
- Curriculum and Instruction
- Sop
- Research
- Cgmp Manufacturing
- Batch Records
- Cell
- Scientific Writing
- Good Documentation Practices
- Cell Culture
- Mass Spectrometry
- Science
- Current Good Manufacturing Practices
- Higher Education
- Aseptic Technique
- Hplc
- Contract Manufacturing
- Laboratory
- Science Education
- Aseptic Processing
- Chemistry
- Biochemistry
- Quality Management
- Biotechnology
- Translation
- Technology Transfer
- R&D
- Bioseparations
- Spanish
- Characterization
- Spectroscopy
- Analytical Chemistry
- Capa
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