Senior Manufacturing Deviation & CAPA Lead

Takeda; Libertyville (IL); On-site; USD 104,000 - 163,000; Full time

Job summary

Takeda is seeking a Manufacturing Investigation Principal Analyst in Illinois to lead investigations of manufacturing and product deviations. You will analyze trends, drive root-cause analyses, and implement CAPAs while ensuring GMP-compliant quality systems.

You will guide teams, communicate with stakeholders, and support regulatory responses as needed. The role requires a Life Sciences or related degree and several years in GMP manufacturing, with strong technical writing and independence.

Qualifications

• Bachelor’s degree required in Life Sciences, Biotechnology, Pharmacy, Engineering or related field.
• Several years in pharma/biotech manufacturing within GMP environment.
• Experience leading deviation investigations and CAPA implementation.
• Strong writing, communication and stakeholder management skills.
• Ability to work independently and support junior colleagues.

Responsibilities

• Lead investigations related to manufacturing and product deviations in the Quality Management System.
• Perform trend analysis on deviations and quality events to identify recurring issues.
• Drive robust root cause analyses and ensure CAPA effectiveness.
• Maintain and improve deviation investigation procedures and quality processes.
• Provide technical guidance on investigation methodologies and compliance.
• Collaborate with stakeholders to ensure timely communication and resolution.
• Support inspection readiness and respond to regulatory observations as needed.
• Mentor junior colleagues and sometimes lead small improvement projects.

Skills

Deviation investigations

CAPA management

GMP knowledge

Root cause analysis

Education

Bachelor's in Life Sciences / Engineering

Job description

Takeda is seeking a Manufacturing Investigation Principal Analyst in Illinois to lead investigations of manufacturing and product deviations. You will analyze trends, drive root-cause analyses, and implement CAPAs while ensuring GMP-compliant quality systems.

You will guide teams, communicate with stakeholders, and support regulatory responses as needed. The role requires a Life Sciences or related degree and several years in GMP manufacturing, with strong technical writing and independence.