Justin Tama

About Justin Tama

An enthusiastic quality professional, with experience in the Biopharma industry…

Experience

1. Sr Manager, Gcp Quality Assurance

   Madrigal Pharmaceuticals

   Sep 2023 — Present

   Ensure clinical trial activities are compliant with GCP, GLP, ICH, FDA, EMA, MHRA and other country regulations, guidelines and industry standards• Align organization to ICH in implementing a quality culture from the outset of clinical trials to promote patient safety and data integrity• Work collaboratively within the QA department and cross-functionally with the functional team members to ensure compliance standards are achieved while contributing to a risk-based QMS• Engage partnership with external vendors via development of Quality Agreements and routine meetings• Attend study team calls in support of ongoing quality and compliance oversight• Lead and coordinate reviews of and report on internal and Vendor Quality Events/Incidents• Track and follow-up on implementation and effectiveness of CAPAs• Lead development, implementation, and maintenance of GCP Quality Systems and SOPs• Contribute to annual audit plans and schedules for GCP/GLP vendors, clinical study sites, etc.• Assure through Qualification audits and oversight activities that clinical trial vendors are operating in compliance with the Company’s quality program, regulations/guidelines and SOPs and are acceptable for performing contracted clinical trial services• Review vendor MSA or contract/Work Orders• Conduct or manage internal/external audits (vendor, site, document, system or process) and prepare or review audit reports• Liaise with stakeholders to obtain responses to audit findings and follow-up to closure• Coordinate on projects serviced by external QA vendors• Review key documents, such as Protocols/Amendments, Consents, IB• Inform and escalate to management in real-time or during routine updates, as appropriate• Participate in inspection readiness activities or provide support during agency inspections• Maintain required knowledge of applicable regulations, guidelines, and company standards and procedures

Education

• North Carolina Central University

  Bachelor of Science (B.S.), Pharmaceutical Sciences

Skills

• Customer Service
• Teamwork
• Chemistry
• Powerpoint
• Microsoft Excel
• Research
• Western Blotting
• Microsoft Office
• Microsoft Word
• Biotechnology
• Protein Purification
• Hplc
• Leadership
• Public Speaking
• Chromatography
• Cell Culture
• Sds-Page
• Pharmaceutical Industry
• Elisa
• Science
• Time Management