My Auditing Journey Ep7 - Marc Helouin
06/20/24 • 52 min
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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Want to follow in Marc's footsteps and become a pharmaceutical auditor? From nurturing early-career talent, to fostering continuous professional development (CPD), RSSL provides you with a comprehensive auditing career path giving you a powerful platform to propel your career further: https://www.rssl.com/training-consultancy/auditing-career-path-training-programme/
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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Want to follow in Marc's footsteps and become a pharmaceutical auditor? From nurturing early-career talent, to fostering continuous professional development (CPD), RSSL provides you with a comprehensive auditing career path giving you a powerful platform to propel your career further: https://www.rssl.com/training-consultancy/auditing-career-path-training-programme/
Previous Episode
My Auditing Journey Ep6 - Peter Rooney
Today we are joined by RSSL Head of Quality Peter Rooney! Starting in analytical chemistry, Peter's career has led him from running a contract lab to becoming a senior manager at UKAS, assessing against many different standards at labs large and small around the world before becoming the one responsible for getting RSSL into audit ready shape.
The two Peters drill down into what auditors want to see in terms of quality control when they visit laboratories, whether that's a multi-site global pharmaceutical brand or a two person operation working out of the side building of a house. They discuss to how to deal with equipment obsolescence, how to gauge "quality culture" and just how much more difficult complex data systems have made the job.
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Want to follow in Peter's footsteps and become a pharmaceutical auditor? From nurturing early-career talent, to fostering continuous professional development (CPD), RSSL provides you with a comprehensive auditing career path giving you a powerful platform to propel your career further: https://www.rssl.com/training-consultancy/auditing-career-path-training-programme/
Next Episode
My Auditing Journey Ep8 - Sam Huff
For our latest My Auditing Journey episode, our host Peter Deegan chats with RSSL Lead Auditor course alumni Sam Huff.
Despite the fact Sam is early in his career, he has already accumulated an impressive amount of experience - and not all of it has been straightforward! Peter and Sam dive in to some of the tricky situations that Sam has found himself in and how these experiences have made him a better auditor.
We also hear about how the Lead Auditor course has shaped his career and what he has learned beyond the classroom, including:
- Why being mentally sharp is crucial when conducting an audit
- The importance of understanding and recalling standards
- How to strike the right tone in an audit and why it matters
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Want to follow in Sam's footsteps and become a pharmaceutical auditor? From nurturing early-career talent, to fostering continuous professional development (CPD), RSSL provides you with a comprehensive auditing career path giving you a powerful platform to propel your career further: https://www.rssl.com/training-consultancy/auditing-career-path-training-programme/
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