Investigations Supervisor

The role

The Investigations Supervisor works with the investigation team to identify root causes and assess product quality impact. This role provides technical support for deviations and implements corrective or preventative measures to improve compliance.

What you will do

• Support area Manager and work with investigators to ensure timely completion of investigations.
• Assign investigations to team members and track them to completion.
• Follow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks.
• Perform investigations and train new investigators.
• Collaborate with team to determine if corrective actions adequately addressed root cause of NC event.
• Support tracking of deviations, events and key process parameters and provide reports to management.
• Identify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
• Implement process improvements within the change control system.
• Serve as project manager for the change process.
• Serve as Subject Matter Expert in preparation for and during internal and external regulatory audits.

Required qualifications

• BS/BA required in technical discipline: Engineering, science or similar field.
• A minimum of six (6) years of professional relevant business experience.
• Demonstrated experience in completing complex investigations independently.
• Knowledge and solid understanding of cGMP regulations and FDA/EU guidance.
• Ability to learn and operate various enterprise systems including eLIMS, TrackWise, Maximo, EMS, BMS, SAP.
• Excellent written and oral communication skills.
• Ability to respond to sensitive inquiries or complaints from top managers, regulatory agencies, or members of the business community.
• Experience with internal and external regulatory audits.
• Ability to utilize various standard programs for data entry and word processing.
• English language proficiency.
• Exposure to and handling of biological materials and hazardous chemicals.

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 time, personal time, sick time, and floating holidays
• Eleven (11) company holidays
• Flexible spending and health savings accounts
• Life and 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. Headquartered in Bridgewater, New Jersey, the company advances cell therapy through innovative technologies.