Manufacturing Investigation, Principal Analyst
Takeda
August 08, 2026
On-site
Libertyville, IL
$103,500 - $162,690 USD yearly
Operations
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.
How you will contribute:
- 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.
What you bring to Takeda:
- 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.
Application instructions:
- By clicking the “Apply” button, your application process will commence; your information will be processed per Takeda’s Privacy Notice and Terms of Use, and you attest the information provided is true to the best of your knowledge.
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.
How you will contribute:
- 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.
What you bring to Takeda:
- 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.
Application instructions:
- By clicking the “Apply” button, your application process will commence; your information will be processed per Takeda’s Privacy Notice and Terms of Use, and you attest the information provided is true to the best of your knowledge.