Orphan Drug Consulting is delighted to welcome Sharon Cullen to its growing international consulting team where she takes up the role of Head of Quality.
Sharon Cullen is Head of Quality for Orphan Drug Consulting with extensive experience in the Life Science industry, having previously held roles in Quality Management 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 joins as a member of the management team and brings applicable experience across quality management. Sharon has been an active EU Qualified Person (QP) for over 25 years and is eligible to act as a Responsible Person (RP). Sharon has led multiple audits and regulatory inspections globally and has experience auditing across GCP, GVP, GMP, GDP, partners, suppliers, and service providers. Sharon has designed and implemented Quality Management Systems following ICH Q10, which included quality council and management governance structures. Sharon has also achieved license approvals to support rapidly growing businesses, facilitated supply chain activities to launch products globally, and implemented various enabling technology platforms. Prior to joining the team, Sharon has held leadership roles in Organon, Merck, LEO Pharma, and most recently Executive Director Quality and Commercial Operations in Jazz Pharmaceuticals.
Sharon holds Masters of Science in Pharmaceutical Manufacturing Technology from Trinity College Dublin (TCD) and in Organisational Behaviour from Dublin City University (DCU). Sharon also holds an MBA from Open University in Buckinghamshire.
Evelyn Kelly, Managing Director of Orphan Drug Consulting commented: “I am thrilled to welcome Sharon to the team as another key member of the management team and quality function at Orphan Drug Consulting. Sharon’s experience speaks volumes, and I am confident her skills and capabilities will be a great asset to our current and future clients. I look forward to working closely with Sharon.”
Sharon adds: “I’ve watched Orphan Drug Consulting expand in the past number of months and I am delighted to join and work alongside the expert team at this exciting time. I see this as an opportunity to leverage my experience and use it as a tool to provide resources to our new and existing clients.”
About Orphan Drug Consulting Ltd
Orphan Drug Consulting coordinate product launch into the US, EU, and other international markets providing strategic support in the areas of supply chain, quality assurance, vendor management, and entity management with its team of experienced industry professionals. From full-service solutions to solving specific immediate requirements, Orphan Drug Consulting is your partner of choice to manage market complexities ensuring your successful product launch to meet your patients’ needs.
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