Associate Director of GCP Quality
A global innovator and leading bio-pharmaceutical company that has been inventing new groundbreaking treatments for numerous life-threatening diseases for more than a century. Through this organisation’s prescription medicines, vaccines, biologic therapies, and animal health products, they work with customers and operate in more than 140 countries to deliver innovative health solutions. Recently a requirement has arisen to recruit an Associate Director of GCP Quality to be based at any of this organisations operation in Ireland OR alternative remote working to oversee and ensure GCP compliance of the organisations clinical trial sites.
- In partnership with the Quality Assurance Lead, the Associate Director of Quality Assurance (AD QA) will support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries
- The AD QA will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients
- The AD QA position is responsible for the execution of the global Quality Assurance (QA) audit activities on assigned studies/products/vendors/Country Offices (CO)
- This role is responsible for GCP oversight, and for assuring the compliance of studies with our Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations)
- 5-7 years of relevant pharmaceutical experience (i.e., drug development, clinical and/or non- clinical research, regulatory compliance, clinical study monitoring or Pharmacovigilance) including at least 3-5+ years previous clinical Quality Assurance experience conducting a broad range of audits.
To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 6321865 for a confidential discussion.
Salary: €2 - €3
Location: Dublin North