- Lead and conduct audits; Issue audit reports and perform follow-up actions
- Review / audit compliance documents, SOPs, and protocols as assigned; report findings to management as necessary
- As required, participate in inspections and audits by regulatory agencies; investigate and resolve observations noted during audits / inspections; participate in inspection readiness activities
- Maintain a current GLP training program to ensure that personnel are appropriately trained to carry out assigned responsibilities
- Conduct audits to monitor the state of compliance of service providers.
- Interact with and influence colleagues in Research division and Research Quality in order to strategically align and facilitate harmonization of quality systems, procedures, and processes where necessary.
- Reading, interpreting and applying various regulations and guidance documents. Assessing compliance with said documents.
- Additional duties as assigned
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Travel required, approximately 25-35%, both domestic and international.
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