Carlos Lopez Rivera

About Carlos Lopez Rivera

I am a Quality Compliance and technical expert in Biotechnology and Diagnostics with over 25 years of experience within FDA-regulated industries (CDMO, biotechnology, medical device/IVD, pharma, and healthcare). My background ranges from pre-clinical, clinical studies/ development/ manufacturing into commercialization. The depth and versatility of my professional curriculum is key to understanding the business from a compliance, regulatory and technical point of view. This along with a dynamic energetic personality instills trust and reliability with Customers and Suppliers for a successful Quality support.In addition to my Ph. D in Biomedical Sciences, a Master Six Sigma Certificate and an ASCP MT certification, my expertise includes experience in pharmaceutical CDMO/CRO and diagnostics medicine- 20+ years GxP (GCP, GMP, GLP, GCLP, GDP), 15 within Leadership Management roles- 15+ years QA (15 as Auditor/Inspector FDA-regulated field; 8+ CDMO Pre/Post Commercial)- IVD/Companion Diagnostics/Medical Device/Combination Products Compliance SME supporting Global markets and regulations (e.g. EU-CTR, MDR, MDGC, Germany MDCG, China NMPA, and FDA)- Global Regulatory Compliance (FDA, EMA, MRHA, ANVISA, Health Canada, Belgium, NMPA, PMDA, IVDR, EU-CTR, ISO 13485/14155/20916, ICH, CLIA, CAP, TJC, AHCA)- QMS (TrackWise, Veeva/Vault, DMS, ComplianceWire, TESLA, OneTrack, MasterControl, SAP, JDE, LIMS)- QA Compliance/Technical SME in GCP/GMP Deviations, CAPAs, Change Controls, and Complaints/SUSARs - 15+ years Customer-Facing and Business Management Roles (QA Liaison/ Technical Manager within CDMO/CMC/CRO/Healthcare/Diagnostic spaces)- 18+ years designing, developing and implementing QMS, SOP’s, and process/ equipment validation for pharma/ clinical/ research laboratories, and immunoassays- Phase-appropriate Quality approach expert (Pre-clinical, Phase 1 thru 3, Commercialization)- Technical Areas: Neurology/Molecular Oncology/ Immunology/ Infectious Diseases/ Cell Therapy- 10+ years Diagnostics/ Medical Liaison/Expert Consultant in Immunology and OncologyI also have a total of six College of American Pathologists (CAP) LAP Inspections (4 as Inspector; 3 as Supervisor), and seven years teaching and mentoring (Community/ Junior College, University and Medical School).

Experience

1. Manager, Clinical Process Compliance

   AbbVie

   Aug 2023 — Present · US

   GCP compliance support for the GBO (Global Business Operations) division. Lead investigations for study program deviations, issues, nonconformance, escalations, exception reports, and change controls. Support clinical study/ site inspection/audit readiness (e.g. MHRA, EMA, FDA, ANVISA, Health Canada, Belgium, NMPA, and PMDA). GCP Consultant support to Site Management/ Monitoring business process and Neuroscience and Immunology Therapeutic Areas. IVDR/ Combination Products Compliance SME supporting EU and FDA regulations. GCP and GLP compliance and regulatory support with QMS like Veeva Vault, OneTrack, TrackWise/SolTRACKS, and TESLA Salesforce.Regulatory compliance and guidelines oversight (e.g. 21 CFR Parts 11, 210, 211, 810; ISO 13485, 20916 and 14155). IVD/Companion Diagnostics/Medical Device/Combination Products Compliance SME supporting Global markets and regulations (e.g. EU-CTR, MDR, MDGC, Germany MDCG, China NMPA, and FDA).

Education

• Interamerican University of Puerto Rico

  Bachelors of Science, Biology, General

  1993 — 1998

• Universidad Intermericana de Puerto Rico

  Post-Graduate Professional Certificate, Clinical Laboratory Science/Medical Technology/Technologist

  1998 — 2000

• Ponce Health Sciences University School of Medicine

  Doctor of Philosophy (PhD), Biomedical Sciences, General

  2002 — 2010

• Villanova University

  Six Sigma Master Certificate, Six Sigma and Lean Manufacturing

  2006 — 2007