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Clinical Quality and Compliance Director

Quality & Laboratory
Dublin
Claire McGuckin
Permanent
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Job Reference: JO-2004-65165_1588250030

Summary:

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

  • 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.

  • 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

  • Leads intra/inter-departmental teams and/or projects that support 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.

  • Leads intra or interdepartmental teams of an operational nature such as preparing the Company for minor changes in regulations, continuous improvement initiatives.

  • Fosters a commitment to quality in individuals and a culture of quality within the organization.



Qualifications



  • BA or BS and 10-12+ years of relevant experience (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.

  • Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.

  • Excellent organization skills and project management.

  • Able to work equally well as part of a team or independently

  • Ability to travel approximately 25% required.



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Claire McGuckin
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Quality & Laboratory
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