Job Reference: JO-2004-65165_1588250030
- 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.
- 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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