(Senior) Clinical QA Specialist
6 days ago
**Location**:
- StevenageThe (Senior) Clinical Quality Assurance Specialist is responsible for quality oversight activities within Clinical development by supporting and managing cross-functional relationships with business process owners and external stakeholders. Maintains Quality Assurance oversight in Clinical Operations and Clinical Development. This is a high visibility position in the organisation with great impact potential and huge development opportunities. In addition, the role also supports compliance of the Autolus quality management system.
The role is key within the overall Quality organisation at Autolus and ensures that the company remains compliant with GCP / GVP regulations, including activities supporting clinical trials involving ATIMPs. This role encompasses oversight and support of quality system types including paper, electronic or hybrid. Reporting to the Director, GCP QA, the job’s reach spans across several manufacturing sites plus multiple clinical trials.
Key Responsibilities
- Support the development and implementation of the risk-based audit plan for GCP/GVP-regulated activities.
- Support the planning, conduct and follow-up activities of audits for vendors, contract research organizations (CROs), clinical investigator sites, trial master file, and internal business processes within clinical development and operations.
- Provide QA support to Clinical project teams.
- Support the development and maintenance of the quality management system in conjunction with the Quality team and other stakeholders.
- Manage, review, and approve quality events, including deviations, investigations, and corrective and preventive actions pertaining to the GCP/GVP area.
- Authoring, review, and approval of Clinical QA and GxP procedural documents - In collaboration with relevant stakeholders develop, implement, maintain, and improve policies, procedures, and associated plans for Clinical QA.
- Promote Good Documentation Practice within clinical project functional areas.
- Support the administration of the Trial Master File TMF system (including but not limited to user management, configuration, and validation).
- Administration management of all relevant eQMS systems used at Autolus within a GCP environment to ensure they are managed in a controlled, traceable, and auditable manner and ensure the principles of data integrity are upheld.
- Collaborate with stakeholders to identify process gaps and recommend solutions.
- Provide GCP/GVP metrics on compliance and present at quality review meetings and/or functional meetings.
- Assist with regulatory inspections e.g., MHRA, FDA, EMA etc Including inspection co-ordination activities.
- Support clinical inspection readiness activities.
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