Senior Director, Clinical Quality Assurance
Alkermes
This Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes GLP/GCP/GVP quality programs to ensure compliance across global clinical trials. This leader ensures the organization is ready for inspections, implements and manages risk-based quality systems, collaborates across departments to advance development programs, and supports the team for NDA/BIMO milestone achievements. This role requires an experienced Clinical QA Senior leader who can build high-performing teams, influence in a matrixed environment, anticipate and respond to evolving regulatory expectations.
Responsible for the Clinical Quality Assurance (CQA) unit within the Alkermes organization. The CQA unit consists principally of a team based out of Waltham supported by individuals across the sites and Contract Auditors on "an-as-required" basis.
A member of the Alkermes Quality leadership teamresponsible for overall Quality culture and continuous improvement of Alkermes QMS and compliance, and leads the Alkermes strategy and GXP compliance on all matters concerning Quality in the areas of; Good Laboratory Practices (GLP), Good Clinical Practices (GCPs), and Good Pharmacovigilance Practices pre and post market (GVPs).
Directs a team in the development of all applicable; risk-based audit programs, inspection readiness and hosting of Health Authority Inspections.
#J-18808-LjbffrVacancy posted 5 hours ago
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