Manufacturing Investigation, Principal Analyst

About the role:

As a Manufacturing Investigation Principal Analyst, you will lead the investigation and resolution of product and process deviations to ensure quality, compliance, and reliability of manufacturing operations. You will work cross-functionally with Manufacturing, Quality, Engineering, and Supply Chain teams to identify root causes, drive corrective and preventive actions (CAPAs), and continuously improve manufacturing processes.

• Lead and coordinate deviation investigations within the Quality Management System.
• Perform trend analysis on deviations and quality events to identify recurring issues and process improvement opportunities.
• Drive root cause analysis and ensure effective CAPA implementation.
• Maintain and continuously improve deviation investigation procedures and associated quality processes.
• Provide technical expertise on investigation methodologies and compliance requirements.
• Partner with stakeholders to ensure timely communication, escalation, and resolution of quality events.
• Support inspection readiness and responses to regulatory observations (when required).
• Participate in continuous improvement; occasionally lead small projects or mentor junior colleagues.

• Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, Engineering, or related scientific discipline (required).
• Several years of GMP-regulated pharmaceutical/biotech/biologics manufacturing experience.
• Experience leading deviation investigations, root cause analysis, and CAPA management.
• Strong GMP and pharmaceutical quality system knowledge.
• Experience with quality management systems and regulated investigation workflows.
• Excellent technical writing, communication, and stakeholder management skills.
• Ability to work independently, manage competing priorities, and support less experienced colleagues.