Title: Global Quality, QA Clinical Operations Manager (Part Time)
Reports To: Head, Global Quality R&D Operations
Delivery of Indivior (INDV) Good Clinical Practices (GCP) Quality Assurance (QA) Operations program. This position plays a lead role within Indivior’s GCP QA process, works closely across Indivior Quality, functional Compliance teams and the Research & Development (R&D) matrix to ensure the R&D Quality Management System (QMS) results in clinical trials that meet global regulatory and business requirements. This position represents the company both internally and externally. Lastly, the position helps to drive a ‘culture of quality’ at Indivior.
The responsibilities of this job include, but are not limited to, the following:
- Support qualification, routine, and for-cause audits of Clinical Research Organizations (CRO), investigator sites, laboratory, and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts.
- Ensure quality incidents are fully investigated, root cause analysis is defined and that CAPA has been implemented and monitored for effectiveness.
- Evaluate audit, regulatory and industry trends to identify potential compliance risks and continuous improvement initiatives.
- Reporting of key metrics (KPIs), quality metrics, periodic quality reports and audits as needed.
- Lead cross functional GCP Quality Management Review (QMR) meetings in collaboration with Global Medicines Development.
- Ensure timely collaboration with Global Medicines Development staff to ensure any non-compliance is elevated appropriately and addressed in a timely manner.
- Advise Global Medicines Development team regarding aspects of GCP and compliance to standard operating procedures and regulatory requirements.
- Prepare Quality Agreements for review and approval, as applicable.
- Lead specific global R&D initiatives aimed to strengthen the Quality Management System, as required.
- Review and approve clinical process deviations for compliance and completeness.
- Engage cross-functionally with process owners and functional area leads to review key quality indicators and communicate quality and compliance risks and remediation plans to quality leadership.
- Serve as a key point of contact for quality assurance questions/issues for clinical programs and studies.
- Monitor functional metrics to determine compliance with processes and procedures and evaluate data for potential trends and signals.
- Conduct review of clinical Standard Operation Procedures (SOPs) and serve as first line quality approver.
- Serve as the Quality Assurance point of contact for clinical vendors.
- Conduct site and sponsor inspection readiness preparation, including the identification of key risks and mitigation strategies, coordinating site inspection management activities, and facilitating inspection responses as appropriate.
- Maintaining current working knowledge of regulations that impact the role.
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