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QMS Quality Manager at Thermo Fisher Scientific who cut CAPA extensions from 53% to 14% and leads site Management Review reporting.

United States

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At Thermo Fisher Scientific, I lead site Quality Systems governance for ISO 13485:2016-regulated IVD operations. I established and lead the Monthly CAPA Review Board and present CAPA and change-control performance, trends, and risks at site Management Review.

I reduced the proportion of CAPAs requiring extensions from 53% to 14% by implementing an overdue-CAPA escalation process with owner accountability and recovery planning. I also led a cross-functional, multi-site change-control Kaizen that reduced average cycle time from 289 days to 108 days.

At INDIVIOR, I worked remotely as a Quality reviewer and approver in Veeva QualityDocs, Veeva QMS, Veeva Vault RIM Suite, and TrackWise. I reviewed controlled documents, change controls, deviations, and validation records while supporting pharmaceutical Quality and Validation oversight.

Earlier, at PFIZER INC., I supported capital-project validation and pharmaceutical process engineering, including equipment qualification and change management. I’m a Certified Root Cause Investigator Trainer and hold Lean Six Sigma Green Belt and CAPA Academy Gold certifications.

Experience

Work history, roles, and key accomplishments

Current

QMS Quality Manager

Current

Thermo Fisher Scientific

Dec 2022 - Present (3 years 10 months)

Lead site Quality Systems governance within ISO 13485:2016-regulated IVD manufacturing, including CAPA, change control, and Management Review. Reduced CAPA extensions from 53% to 14% and change control cycle time from 289 days to 108 days.

Veeva Vault QMS Veeva Vault QualityDocs CAPA Change Control Root Cause Analysis ISO 13485 MDSAP Excel Dashboard Management Reviews Audit Readiness Training Supplier Audits Validation Harmonization CMMS Data Integrity

Quality / Validation Engineer

Indivior

Dec 2020 - Dec 2022 (2 years)

Provided remote Quality and Validation oversight for pharmaceutical product lines, GxP computerized systems, and outsourced manufacturing. Reviewed and approved controlled documents, change controls, deviations, and validation records in Veeva and TrackWise.

Veeva Vault QualityDocs Veeva Vault QMS Veeva Vault RIM Suite Trackwise GAMP 5 Best Practices 21 CFR Part 11 EU GMP Annex 11 Risk Based Validation Data Integrity Change Control Deviation Management CAPA IQ OQ PQ Validation Cleaning Validation

Principal QA Validation Engineer

Pfizer Inc.

Apr 2018 - Dec 2020 (2 years 8 months)

Led QA/validation oversight for complex capital projects involving high-throughput filling, packaging, and inspection systems. Directed development and approval of validation strategies, protocols, and reports, applying ICH Q10 and GxP requirements.

Validation Strategy URS Risk Assessment IQ OQ PQ Validation ICH Q10 EU Annex 1 EU GMP Annex 11 Change Control Data Integrity Cross functional Coordination Regulatory Inspections

Sr. Process Engineer

Pfizer Inc.

Jun 2016 - Apr 2018 (1 year 10 months)

Managed change controls, CAPAs, and technical impact assessments across controlled pharmaceutical manufacturing processes. Supported product lifecycle activities from technology transfer through validation and commercial manufacturing.

Change Control CAPA Process Capability Analysis Risk Based Decision Making Technology Transfer Validation Regulatory Inspections Leadership Support

Process Engineer

Cambridge Major Laboratories

Aug 2015 - Jun 2016 (10 months)

Supported API development and scale-up in a kilo-lab manufacturing environment, contributing to process design, risk assessment, and operational readiness. Coordinated with contractors during construction of new laboratory space.

API Development Scale Up Risk Assessment Document Control Facility Startups Operator Training

Process Engineer

Bayer Animal Health

Apr 2012 - Jul 2015 (3 years 3 months)

Supported oral solid dosage pharmaceutical manufacturing, technology transfer, and scale-up during a major transfer program. Applied ICH Q10 principles and coordinated with a CMO for technical transfer.

Oral Solid Dosage Technology Transfer Scale Up ICH Q10 Validation Change Control CAPA CMO Coordination Cross Site Communication

Project Engineering Specialist

SAFC Biosciences

Feb 2011 - Mar 2012 (1 year 1 month)

Coordinated supplier and material Quality documentation with Purchasing and external vendors. Built release and transfer tracking for 200+ chemical products to improve visibility and readiness.

Supplier Quality Documentation Certificate Of Analysis Testing Methodologies Specification Changes BSE TSE Trackings Forecasting

Research Assistant

University of Kansas

Jan 2009 - Dec 2010 (1 year 11 months)

Conducted biomedical research, analytical characterization, cell culture, experimental design, and technical presentation.

Biomedical Research Analytical Characterization Cell Culture Experimental Design Technical Presentations

Microbiologist

Reser's Fine Foods

Jun 2007 - Jan 2009 (1 year 7 months)

Performed microbiological testing, GLP laboratory controls, environmental monitoring, and hold/release recommendations.

Microbiological Testing GLP Environmental Monitoring Hold Release

Education

Degrees, certifications, and relevant coursework

Thermo Fisher Scientific

Certified Root Cause Investigator Trainer, Root Cause Investigation

Completed a 23-hour investigator-trainer program covering 17 modules and 31 topics, qualifying to train and coach personnel in structured root cause investigation methodology.

Thermo Fisher Scientific

Lean Six Sigma Green Belt, Lean Six Sigma

Applied continuous-improvement and Kaizen methods to Quality-system process performance.

Pfizer

Agile Project Management, Project Management

Agile Project Management certification from Pfizer in 2021.

ProPharma

Process Validation Training, Process Validation

Process Validation Training from ProPharma in 2014.

St. Louis University

Bachelor of Science, Biomedical Engineering

Bachelor of Science in Biomedical Engineering from St. Louis University, Parks College of Engineering, with a minor in Engineering Mathematics, completed in May 2007.