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QA Operations Lead
- New Haven, Connecticut, United States
- New Haven, Connecticut, United States
Über
Brief Job Profile Description Guide the execution of core processes related to clinical finished product release and distribution, including managing deviations, 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.
Typical Accountabilities
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 negotiations 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.
Qualifications and Skills
Essential : High school education with significant experience or 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.
Minimum Experience: 8+ years
Industry: Pharmaceutical/Biopharmaceutical
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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Sprachkenntnisse
- English
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