Cache of job #14123361

Job Title

Director, Gcp, Quality And Compliance

Employer

CPL

Location

DUBLIN CITY CENTRE

Description

Director of Clinical Compliance. On behalf of my client I am recruiting for a Director of Clinical Compliance. The successful candidate will support and work with the organizations clinical study management teams and teammates across R&D Quality and Compliance. You will be a part of an expert team supporting global clinical development programs, with a special emphasis on pediatric trials, based in Dublin, Ireland. Responsibilities: Active member of the R&D Quality and Compliance Clinical management team. Lead Clinical Compliance activities and compliance staff in one or more therapeutic areas. Handle multiple projects and ensure overall and timely completion of tasks. Works closely with compliance staff and clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement. Support deviation identification, reporting, and CAPA development and responsible for ensuring the development of audit strategy plan(s) and ensuring timely execution of plans for programs. Oversees GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors, and represent Regulatory Compliance in Working Groups as appropriate. Leads intra/inter-departmental teams and/or projects supporting continuous improvement of the Quality Management System. Builds positive support and acts as role model for change. May lead/support management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management. Qualifications: BA/BS and 12+ years of relevant experience OR 10+ years of relevant experience with an MS. Must have significant GCP audit and compliance experience. Clinical Quality Assurance/Compliance experience required. Bio-pharma sponsor or CRO experience required. Significant experience with pediatric clinical trials strongly preferred. Recognized as an expert resource on a range of clinical compliance topics. Strong verbal and written communication skills and interpersonal skills, and excellent organization skills and project management. Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred. If you are interested in applying for this role, please call Ciara on +353 1 2784671 or email cphillips@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com.

Date Added

1324 days ago

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