Job Description

Director of Clinical Quality and Compliance

Ref No: SF17201

Co. Dublin, Ireland

Competitive salary

Director of Clinical Quality and Compliance- Dublin

Core Purpose

A Director Clinical Quality & Compliance is required to join a leading biopharmaceutical company based in Dublin. You will support and work with their clinical study management teams and teammates across R&D Quality and 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.

Core 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 & Experience:

• Degree qualified in a Bachelor of Science and 12+ years of relevant experience OR 10+ years of relevant experience with a Masters.
• 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.