Hobson Prior are looking for an Associate Director to join a top science-based biopharmaceutical organisation to join them on a permanent basis in Uxbridge or Dublin. As the Associate Director you will work with GCP Quality Improvement team to ensure processes and procedures are followed effectively and investigate any potential issues.

Job Responsibilities:

• Work with GCP Compliance & Process Teams to recognise opportunities to streamline and strengthen GCP processes
• Serves as GCP SME when SOPs are written or revised
• Manage Quality Events and Actions within regulated Quality Management System
• Represent GCP knowledge on cross-functional teams for GCP related process improvements resulting from new/revised regulations or guidance
• Leads cross-functional rapid response teams for identified GCP process violations needing immediate remediation
• Work closely with Regulatory Intelligence team to identify changes in global regulations affecting current processes as they relate to GCP

Key Skills:

• Excellent communication skills and ability to work with people in all levels of the organisation and externally.
• Ability to take initiative and working independently.
• Self-motivated with the ability to work effectively in a dynamic environment.
• Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organisation.

Requirements:

• 5 years' experience working in either a clinical compliance group, QA Quality Management/Quality Risk Management function, or Clinical Development with expertise and/or transferrable skills with Good Clinical Practice and Regulatory Inspections.
• Demonstrated Quality Management System experience (GCP specific QMS experience preferred).
• Demonstrated Issue Management and CAPA experience in a clinical environment.
• Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
• Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.