Roberto Bracamontes
Sr Director Program Quality Rare Diseases @Recordati
Signup · Get unlimited contacts
WORK HISTORY
Sr Director Program Quality Rare Diseases @Recordati
Bridgewater, NJ, US
Lead QA strategy and operations for the global Rare Disease Business Unit, ensuring all products comply with regulations, corporate quality standards, and industry best practices. Serve as Quality steward across the portfolio. Work with R&D, Regulatory Affairs, Manufacturing, Commercial teams, and CMOs to help deliver safe and effective therapies to patients.
EDUCATION
Universidad de Guadalajara
Bachelor's of Sciences, Biology
ABOUT ROBERTO BRACAMONTES
At Grifols, over 2.5 years were dedicated to leading Quality Assurance operations for immunodiagnostics and contract biologics manufacturing. The team focused on batch disposition, deviation management, CAPA, risk management, and QA validation, ensuring operational excellence and compliance in highly regulated environments. Our goal is continuous improvement and promoting Quality as a business partner.Previous roles at Myovant Sciences, AstraZeneca and Novartis emphasized document control improvements, training program enhancements, and site compliance initiatives. Expertise in complaint management and validation has consistently supported the development of robust quality systems, reinforcing the organization\'s commitment to meeting the highest regulatory standards. Advancing team performance has always been enjoyable.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.