Quality Assurance Specialist (Regulatory Affairs) - Clinical Trials

Overview of Role:

Collaborate closely with Regulatory Affairs, QA, R&D and other cross-functional teams within Summit to provide GCP/GLP/GPV and compliance-related advice to internal clinical study teams. Ensure tactical support is provided to assignments and take the lead in ensuring project-related procedural documents comply with relevant GxPs and regulatory requirements and guidelines.

Role and Responsibilities:

• Partnering and collaborating with key stakeholders (R&D teams) to ensure appropriate Quality support is provided to Summit Clinical and pre-clinical programs.
• Managing Audits which include Clinical Sites and Vendor Qualification.
• Ensuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP).
• Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions.
• Supporting CRO-relevant meetings, when necessary, to provide quality overview/training to relevant stakeholders.
• Providing support during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed.
• Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course.
• Identifying areas of continuous process improvement and engaging QA and key stakeholders as necessary.
• QA support in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with the Global RD/PV QA team, ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections.
• Support in providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel for assigned programs or for continuous improvement projects.
• Supporting or leading development and driving the implementation of study/program-specific quality plans to ensure proactive management of quality.
• Supporting rectification of any necessary vendor-relevant issues identified for the assigned program.
• Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders.
• Perform internal audits in support of the Quality Systems internal audit program.