Madeleine is a seasoned cGMP Quality professional with 20+ years of experience supporting regulated manufacturing and laboratory environments across the product lifecycle. She has conducted multiple quality audits on behalf of QualRS across the EU, bringing a pragmatic, inspection-ready approach to supplier qualification, compliance oversight, and remediation support.

Her background includes serving as a cGMP Quality Manager responsible for biomedical countermeasures (DERA/Dstl) and as UKAS Quality Manager for an analytical chemistry testing laboratory (UKAS Lab No. 1886). Madeleine has hands-on experience with hyperimmune sera, fresh frozen plasma, sterile liquid injectables, “specials,” and investigational medicinal products (IMPs). She is highly experienced in third-party and regulatory inspections and has working knowledge of GDP (including cold-chain logistics) and GCP. She is also IRCA-qualified as an auditor.

Madeleine is skilled in building Quality Management Systems (QMS) from the ground up, mentoring and training staff, and leading internal and external audits. Her technical validation experience includes protocol development for manufacturing scale-up intended for both European and U.S. markets. She has also supported the acquisition of manufacturing licenses in the UK and Australia, including engagement with Australia’s TGA.