Ref No: AM17201
Co. Dublin, Ireland
Director - GCP Quality & Compliance.
Our client seeks a Clinical Quality and Compliance Director who is ready to dive-in to support clinical development programs. As a Clinical Quality and Compliance Director, you will support and work with clinical study management teams and teammates across R&D Quality and Compliance.
We seek someone with strong leadership skills, expert Good Clinical Practice (GCP) knowledge, audit skills, communication, and facilitation skills, and the ability to manage multiple projects. You will be a part of an expert and supportive team that fosters constructive collaboration in support of clinical development programs.
You will be a part of an expert team supporting global clinical development programs, with a special emphasis on paediatric trials
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.
Work 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
Responsible for ensuring the development of audit strategy plan(s) and ensuring timely execution of plans for programs.
Oversee GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors.
Represent Regulatory Compliance in Working Groups as appropriate
Supervise, develop, train and manage internal staff as appropriate.
Ensure oversight of contracts auditors.
Effective compliance reporting to senior management and relevant quality governance forums
Lead intra/inter-departmental teams and/or projects that support continuous improvement of the Quality Management System. Builds positive support and act as role model for change.
May lead/support management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management.
Lead intra- or inter-departmental teams of an operational nature such as preparing the company for minor changes in regulations, continuous improvement initiatives.
Foster a commitment to quality in individuals and a culture of quality within the organisation.
Qualifications and experience required:
BA or BS and significant relevant experience
Must have significant GCP audit and compliance experience.
Clinical Quality Assurance/Compliance experience required.
Bio-pharma sponsor or CRO experience required.
Significant experience with paediatric clinical trials strongly preferred.
Recognised as an expert resource on a range of clinical compliance topics.
Strong verbal and written communication skills and interpersonal skills.
Experience with audit management/CAPA management programs strongly preferred.
Excellent organisation skills and project management.
Able to work equally well as part of a team or independently
Ability to travel approximately 25% required.