Director of Clinical Quality and Compliance
Ref No: SF17201
Co. Dublin, Ireland
Director of Clinical Quality and Compliance- Dublin
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.
- 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.
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