7 - Marc Helouin

My Auditing Journey

This week we are joined by Wheeler Bio's Chief Quality and Regulatory Officer Marc Helouin!

To say Marc has had a varied career would be an understatement. A trained Pharmaceutical Auditor with 25 years of Biopharma experience under his belt including Corporate Head of Audit (R&D) for AstraZeneca and leadership roles at other major pharma companies, Marc has been involved with domains ranging from quality assurance, corporate audit, supply chain assurance, commercial compliance and more.

Coupled with his degree in chemistry, Marc also holds a law degree and is a member of the bar for the state and federal courts of Ohio, as well as being a member of the bar of the Supreme Court of the United States. As if this isn't enough, Marc is also a graduate of the US Navy's Nuclear Power School, subsequently rising to the rank of lieutenant commander.

With a CV as long as your arm Peter and Marc found plenty of fertile ground to cover on Marc's experience of auditing, not only on both sides of the table but both sides of the Atlantic. Marc shares how his background in law helped his auditing, how crucial frameworks can be when investigating GMP environments, how being proactive auditee can work to your benefit and just how difficult it can be navigating an audit where English isn't necessarily the first language.

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