Héctor Manuel López López
Associate Director CMC QA @ Ultragenyx | Manufacturing Process Improvement, Business Process Improvement
- Role
- Associate Director Cmc Qa at Ultragenyx
- Location
- Novato, CA, US
- LinkedIn followers
- 500 followers
About Héctor Manuel López López
Quality professional with 11+ year experience on small and large molecule in the Biotech and Pharmaceutical industry from early phase through commercial manufacturing- Hands-on collaborative team leader focused on right-sized, risk based, data-driven solutions and effective utilization of resources- Expertise in Multi-discipline team projects - Committed to achieving goals and delivering results while working under pressure- Enthusiastic, persistent, motivated and a team player with problem solving skills- Proficient in cGMP, 21 CFR Parts 210 and 211 and ISO 14644 for Cleanrooms and associated controlled environments- Specializing in sterilization validations
Experience
Associate Director Cmc Qa
Feb 2025 — Present
Providing technical expertise to clinical and commercial CMC teams to ensure successful implementation of global and product strategies• Onboarding and qualification of Contract Organizations, including risk assessments and negotiation and approval of Quality Technical Agreements• Lead Annual Product Quality Review program for all commercial products (US, EU, JP, LATAM), including internal and external operations• Lead Product Complaints function ensuring product quality, patient safety, and full compliance through clinical and commercial product phases.• Disposition of clinical, and commercial products (DS, DP and Finished Goods) at CMOs in partnership with Technical Operations, Reg CMC, Product Development, Supply Chain and other functions.• Design, implement and lead Change Control Review Board in collaboration with cross-functional leadership: CMC Manufacturing, Supply Chain, Packaging, CMC QC, Technical Development, Regulatory Affairs, Clinical QA and CMC QA.
Education
University of California, Irvine Division of Continuing Education
Course, Project Management
2020 — 2020
University of Valencia
Master's degree, Pharmaceutical Care
2005 — 2006
The University of Manchester
Course, Industrial Biotechnology
2020 — 2020
Universidad Internacional de La Rioja
Master's degree, Teaching in Obligatory Secondary and Upper Secondary School Education,Vocational Training
2010 — 2011
Universidad Complutense de Madrid
Bachelor of Pharmacy (B.Pharm.)
1999 — 2004
Centro de Estudios Superiores de la Industria Farmacéutica (CESIF)
Master's degree, Pharmaceutical and parapharmaceutical industry
2013 — 2014
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