Sharon Cullen is Head of Quality for Orphan Drug Consulting, she has extensive experience in senior leadership roles in the Life Science industry with a focus on the Pharmaceutical Quality System (PQS) including auditing, regulatory inspections, lean and continuous improvement, compliance, quality excellence, training, management review, CMO oversight, quality data integrity, analytics and enabling technologies, affiliate quality oversight, and global quality operations including QP responsibilities, QC laboratory and packaging.
Sharon is a core member of the Orphan Drug Consulting management team and brings applicable experience across quality management. Sharon has been an active EU Qualified Person (QP) for over 25 years. She has led multiple audits and regulatory inspections globally and has experience auditing across GCP, GVP, GMP, GDP, partners, suppliers, and service providers. Prior to joining the team, Sharon has held leadership roles in Organon, Merck, LEO Pharma and most recently was the Executive Director Quality and Commercial Operations in Jazz Pharmaceuticals where she built the Quality team, achieved licence approvals to support the rapidly growing business, facilitated supply chain activities to launch products globally and implemented various enabling technology platforms.
Sharon is focused on leading teams to develop quality systems that ensure regulatory compliance, product efficacy and patient safety from a pragmatic business driven perspective.
Sharon holds a Master of Science degree in Pharmaceutical Manufacturing Technology from Trinity College Dublin (TCD) and another in Organisation Behavioural Science from Dublin City University (DCU). She also holds an MBA from Open University in Buckinghamshire.