Job Description
On behalf of my client, a global pharmaceutical company, we have a new vacancy for a Clinical Quality Manager (GCP) to join the team in Dublin. This is a permanent role with hybrid offering. Fantastic opportunity to join a fast-growing organisation with an exciting portfolio pipeline. Clinical Quality Manager (GCP) You will be responsible for ensuring compliance with SOPs, GxP, European regulations, local regulations and guidelines, and clinical study protocols. This position will collaborate with other global functions such as Clinical Operations, Medical, Regulatory, Project Management, and Pharmacovigilance. Responsibilities: Establish an appropriate system for clinical quality management and oversight of investigational sites and vendors. Collaborate with stakeholders in the cross-functional departments (Clinical Operations, Project Management Office, Medical, Regulatory, PV, etc.) to support clinical trial programs for the organisation for both new compounds and new indications for marketed products. Maintain GCP/ICH compliant systems and processes which control the quality of work and clinical trials conducted globally and locally, where required. Support in writing clinical documented processes in applicable SOPs and support continuous process improvements. Ensure processes comply with applicable Standard Operating Procedures (SOPs) and regulations. Manage inspection readiness and coordinate its activities. Qualify CRO and other vendors related to the clinical activities. Create risk-based study-specific audit plans, schedule, and conduct investigator site audits per the study audit plan to ensure study conduct at the audited site complies with applicable Regulations and Good Clinical Practice standards. Ensure CRO/investigator monitoring programs are in place to ensure compliance with protocol, GCP, and applicable regulatory requirements and relevant internal policies and procedures for the studies. Support in the management of quality records e.g. change controls, investigations, deviations, and CAPAs to closure. Requirements: University degree (preferably in Life Science). 5-8 years of experience in Clinical Quality oversight from a Sponsor perspective (clinical QA experience in the pharmaceutical industry required). Demonstrated knowledge of ICH GCP, global regulations, and guidelines applicable for the conduct of clinical trials. A complete understanding and application of principles, concepts, and practices of clinical research procedures. Experience in developing audit and/or quality oversight processes in GxP areas. Experience in preparing for and hosting regulatory inspections. Ability to lead and support several concurrent projects and develop strong relationships within cross-functional teams. Strong communication skills both written and verbal. For full details, email your CV to tdunne@thornshaw.com or call Tina at +353 1 2784701 / 087 6811990. Thornshaw Scientific is a division of the CPL Group. www.thornshaw.com #LI-TD1 #J-18808-Ljbffr