Mark Birse

Vice President Technical, Strategic Compliance Consulting

Parexel

Biography

Mark is a strategically orientated regulatory compliance professional, with a career spanning the regulation of pharmaceuticals and medical devices. Mark has a passion for ensuring patient safety through delivering pragmatic, risk proportionate and innovative approaches to regulation. Prior to joining Parexel, Mark worked at the MHRA where held a number of leadership roles, including Head of MHRA Inspectorate. He worked extensively with international regulators including FDA, EMA and TGA developing compliance and risk-based inspection methodologies with a focus on inspection collaboration and reliance. He was an Executive Bureau member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

Mark also held leadership roles in the MHRA Medical Device Division with responsibilities for Devices Safety and Surveillance & Software and Apps. Mark’s background is in GMP having initially joined the MHRA in 2002 as a GMP Inspector where he performed inspections globally. Prior to joining MHRA he spent 10 years in Industry with responsibilities for technology transfer and supplier auditing.

Mark is a Fellow of the Royal Society of Chemistry and has been an eligible Qualified Person since 2003 he is also an IRCA Principal Auditor under the PQMS-GMP scheme.