Biography

Shawn Murtough is Director of Quality and Regulatory Affairs at PCI Pharma Services, bringing over 25 years of experience in the pharmaceutical industry across analytical development, compliance, and quality assurance. With more than 15 years serving as a Qualified Person (QP), he is currently named on both commercial and investigational medicinal product (IMP) licenses in the UK and EU.

Shawn has extensive expertise in regulatory inspection readiness and hosting, having successfully supported inspections by agencies including the MHRA, HPRA, FDA, and ANVISA. He is also a qualified pharmaceutical auditor with international auditing experience spanning APIs (small molecule and biological), excipients, and a broad range of finished dosage forms including sterile products (aseptic, terminally sterilized, ATMPs), solid oral dosage, transdermal systems, and packaging operations.

Throughout his career, Shawn has partnered with a diverse client base from top 10 pharmaceutical companies to virtual biotech start-ups, hospital trusts, and academic organizations providing strategic guidance on quality systems, regulatory compliance, and product lifecycle management.