Mark Birse

Mark is a strategically orientated regulatory compliance professional, with a 30+ years experience in the pharmaceutical, biotech, medical device, and life sciences sector. With a proven track record of challenging norms, developing innovative solutions, and enhancing regulatory compliance, Mark has a passion for delivering regulatory requirements, and ensuring patient safety. 

Work experience

Prior to joining Parexel, Mark worked at the MHRA in a number of leadership roles, including Deputy Director Inspection, Enforcement & Standards Division, Head of MHRA Inspectorate, and Head Devices Safety and Surveillance & Software and Apps. Mark was also an Executive Bureau member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). In all those roles, Mark 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. 

Before working at the MHRA he spent 10 years in industry roles including MSAT, Technology Transfer, Supplier & CDMO Audits, and R&D Quality Assurance.

Education

Mark is a Fellow of the Royal Society of Chemistry and has been an eligible Qualified Person since 2003. He has also completed an MBA in 2020 and is an IRCA Principal Auditor under the PQMS-GMP scheme. He has been deemed eligible by the MHRA to act as a Compliance Monitor (CM) in MHRA’s compliance monitor programme for GMP/GDP remediation supervision activities.