Quality Assurance Operations Lead

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.

Accountabilities

• 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 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.

Qualifications and Skills

• 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.