Job Description
- Guide the execution of core processes related to clinical finished product release and distribution, including managing new product introduction change controls, deviations during packaging & labelling, complaints, and supplier quality.
- Ensure timely data entry and documentation review and approval.
- Lead and approve investigations to establish root causes, track CAPA implementation, and approve investigation reports.
- Provide guidance on GxP, coordinate quality agreement review, change management and actively engage in process improvements and risk assessments.
- Conduct data analysis, develop reports on quality metrics and key performance indicators, and support overall planning for change management and guidance for internal and external stakeholders.
- Provide quality review, oversight and guidance on Change Controls, Deviations, CAPAs and Supplier Change Notifications.
- •Guide execution of core processes applicable to clinical finished product release and distribution.
- Guide timely data entry and documentation related to own quality area.
- Review and approve investigations to ensure root cause is established and relevant CAPAs are in place, and track implementation.
- Lead quality agreement negations and suppliers risk management evaluations for packaging and labeling CMOs
- Conduct / guide ongoing reviews and approvals of documentation as applicable.
- Provide advice on GxP within the site, with reference to guidelines and regulations.
- Actively engage in change management and process improvements and risk assessments, such as benchmarking internal and external quality assurance practices to identify innovative efficient and effective practices.
- Conduct data analysis and development of reports and insights on quality metrics and key performance indicators,
- using digital tools and processes.
- Support inspection readiness during internal audit and agency inspections.
- Essential: bachelor’s degree in science/engineering field such as Pharmacy, Biology, or Chemistry with some experience; Experience with quality processes across multiple areas; Experience interpreting and guiding clinical supply chain managers around principles and concepts of compliance management within a regulated environment; Experience troubleshooting issues across quality areas;
- Desirable: Experience implementing newer digital tools (e.g. Power BI, Smartsheet, Copilot) and technologies related to QA reporting, documentation, and analysis. Must have Veeva Vault experience as a quality approver.
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