Aldwin Aldana Ms, Rqap-Glp, Mrqa

Aldwin Aldana, MS, RQAP-GLP, MRQA, has a wealth of experience in the field of quality assurance within the pharmaceutical and biotech industries. With expertise in Good Clinical Practice (GCP), GxP compliance, and quality auditing, Aldana has held several key positions throughout their career.

Most recently, Aldana served as the Director of Clinical Quality Assurance (GCP) at Bolt Biotherapeutics, where they were responsible for developing and implementing a risk-based GCP oversight process to support clinical programs. This role involved conducting GCP audits, assessing the effectiveness of GCP processes, and supporting the clinical study teams.

Prior to that, Aldana worked as a Clinical Quality Assurance (CQA) Consultant at 2seventy bio, where they provided expert QA advice and strategic guidance to stakeholders. Aldwin played a critical role in integrating quality throughout the clinical development process and driving improved compliance and quality of activities.

Aldana also held senior leadership positions at Immunovant, Ultragenyx Pharmaceutical Inc., and Biogen, where they oversaw clinical quality assurance and GxP compliance activities.

Throughout their career, Aldana has demonstrated expertise in regulatory compliance, data integrity, and inspection readiness. Aldwin has conducted audits, inspections, and reviews to verify compliance with applicable regulations and SOPs. Aldana has also worked closely with cross-functional teams and contract research organizations (CROs) to ensure regulatory compliance and quality in outsourced nonclinical and clinical trials.

In summary, Aldwin Aldana, with their extensive experience and expertise in clinical quality assurance, GCP, and GxP compliance, is a highly skilled professional in the field.

Aldwin Aldana holds a Master's Degree in Regulatory Science from the University of Maryland, Baltimore (UMB), which they obtained from 2015 to 2017. Prior to that, they obtained a Certificate in Quality Assurance and Control for the Drug and Biologic Industry from UC San Diego, which they completed from 2007 to 2009. Aldwin also holds a Bachelor's Degree in Biology from the University of the Philippines, which they obtained from 1999 to 2003.

In addition to their educational achievements, Aldwin has obtained several certifications. Some of these certifications include "Jodi Glickman on Make 'Em Love You at Work" from LinkedIn, "RAPS Member" from the Regulatory Affairs Certification Program, and various LinkedIn and Lynda.com certifications related to leadership, teamwork, and workplace skills.