Investigator I/II

The role

The Investigator I/II leads and manages moderate- to high-complexity quality investigations. This role involves performing root cause analyses and developing CAPAs related to manufacturing, engineering, facilities, equipment, and validation systems.

What you will do

• Lead end-to-end investigations related to manufacturing, facilities, engineering, equipment, and validation.
• Collect and evaluate supporting investigation data.
• Conduct investigations related to facility and environmental monitoring excursions.
• Perform risk and impact assessments related to product quality, patient safety, and regulatory compliance.
• Conduct detailed root cause analyses using structured methodologies.
• Develop and own CAPA investigations and effectiveness checks.
• Drive investigation meetings and cross-functional alignments.
• Support internal audits and regulatory inspections.
• Analyze investigation and deviation trends to identify recurring issues.
• Author investigation reports suitable for regulatory review.

Required qualifications

• BS/BA in engineering, science, or related field.
• 4-6 years of cGMP experience within biotechnology, biopharmaceutical, pharmaceutical, or other regulated industries, and/or 2-4 years of quality investigation experience.
• Proficiency in conducting moderate- to high-complexity investigations, performing risk assessments, and developing CAPAs.
• Experience conducting product impact assessments and applying risk management principles.
• Experience reviewing and interpreting manufacturing, engineering, maintenance, calibration, environmental monitoring, and validation records.
• Technical writing and documentation skills.
• Working knowledge of electronic Quality Management Systems (eQMS).
• Ability to collaborate and influence cross-functional teams.
• Ability to present investigation outcomes to internal audits and regulatory inspections.
• Technical knowledge of biologics, cell therapy, gene therapy, or pharmaceutical manufacturing processes.
• Proficiency in science- and risk-based decision-making and structured root cause analysis methodologies.
• Working knowledge of cGMP regulations, quality systems, and data integrity principles.

Nice to have

• Experience in engineering, facilities, equipment, validation, or quality systems

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight (8) weeks of paid parental leave after three (3) months of employment
• Paid time off including vacation, personal, sick, floating holidays, and eleven (11) company holidays
• Flexible spending and health savings accounts
• AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• Voluntary commuter benefits
• Family planning and care resources
• Well-being initiatives and peer-to-peer recognition programs

Before you apply

• Applicants must be authorized to work in the United States.
• Employment eligibility will be verified through E-Verify.

About the company

Legend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases. The company is advancing the next generation of cell therapy through a portfolio of innovative technologies.