Benjamin Leang

Benjamin Leang, Senior Manager of Quality Operations at PTC Therapeutics, Inc., brings a wealth of expertise in ensuring the integrity and compliance of biopharmaceutical manufacturing processes. In his current role, Benjamin oversees the GMP activities across multiple contract manufacturing organizations (CMOs), playing a pivotal role in maintaining the highest standards of quality assurance for both clinical and commercial products. His leadership involves the development and implementation of robust quality systems, ensuring adherence to regulatory requirements from agencies such as the FDA, EMA, and other international authorities.

Benjamin's key projects often focus on building system maturity through continuous improvement initiatives, including the optimization of deviation management processes and CAPA systems. His deep knowledge of GMP compliance and experience conducting supplier and internal audits enable him to identify potential risks early, implement effective corrective and preventive actions, and foster a culture of quality throughout the supply chain. His expertise in root cause analysis and root cause problem solving ensures that issues are thoroughly investigated and resolved, minimizing impact on product release timelines and patient safety.

With a strong background as a Certified Quality Auditor (CQA), Benjamin is adept at managing complex deviation investigations, conducting risk assessments, and ensuring that all documentation—such as batch records, validation reports, and regulatory submissions—meets stringent quality standards. His strategic approach to quality operations supports PTC Therapeutics’ mission to deliver innovative therapies, ensuring that products are manufactured in compliance with GMP and regulatory expectations, ultimately safeguarding patient health and advancing the company’s reputation in the biopharmaceutical industry.