QA Operations Lead

Job Description

Job Summary:

• 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 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.

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.
• 8+ years of minimum experience required.

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.