Manufacturing Investigation, Principal Analyst
About The Position
As a Manufacturing Investigation Principal Analyst, you will play a key role in ensuring the quality, compliance, and reliability of Takeda's manufacturing operations by leading the investigation and resolution of product and process deviations. Acting as a subject matter expert in deviation management, you will work cross-functionally with Manufacturing, Quality, Engineering and Supply Chain teams to identify root causes, drive corrective and preventive actions, and continuously improve manufacturing processes. Your work will help ensure compliance with global regulatory expectations while strengthening operational excellence and product supply continuity.
Requirements
- Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Engineering or a related scientific discipline required.
- Several years of experience in pharmaceutical, biotechnology or biologics manufacturing within a GMP-regulated environment.
- Demonstrated experience leading deviation investigations, root cause analysis and CAPA management.
- Strong understanding of Good Manufacturing Practices (GMP) and pharmaceutical quality systems.
- Experience with quality management systems and investigation workflows in a regulated manufacturing environment.
- Proven ability to identify process weaknesses and implement sustainable improvements.
- Excellent technical writing, communication and stakeholder management skills.
- Ability to work independently, manage competing priorities and support less experienced colleagues when required.
Responsibilities
- Lead and coordinate investigations related to manufacturing and product deviations within Takeda's Quality Management System.
- Perform trend analysis on deviations and quality events to identify recurring issues and opportunities for process improvements.
- Drive robust root cause analysis activities and ensure effective implementation of corrective and preventive actions (CAPAs).
- Maintain and continuously improve deviation investigation procedures and associated quality processes.
- Provide technical expertise and guidance to manufacturing and quality teams on investigation methodologies and compliance requirements.
- Partner with internal and external stakeholders to ensure timely communication, escalation and resolution of quality events.
- Support inspection readiness and contribute to responses to regulatory observations when required.
- Participate in continuous improvement initiatives and occasionally lead small projects or mentor junior colleagues.
Benefits
- medical, dental, vision insurance
- a 401(k) plan and company match
- short-term and long-term disability coverage
- basic life insurance
- a tuition reimbursement program
- paid volunteer time off
- company holidays
- well-being benefits
- up to 80 hours of sick time per calendar year
- up to 120 hours of paid vacation for new hires
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What This Job Offers
Job Type
Full-time
Career Level
Principal
