Investigations Supervisor (Biotech)

TL;DR

Investigations Supervisor (Biotech): Overseeing quality investigations and process improvements for advanced cell therapy manufacturing with an accent on regulatory compliance and root cause analysis. Focus on coordinating cross-functional teams, managing change control projects, and serving as a Subject Matter Expert during regulatory audits.

Location: Must be based in Raritan, New Jersey, United States

Salary: $86,944–$143,796 per year

Company

A global biotechnology company developing advanced cell therapies to treat life-threatening diseases.

What you will do

• Supervise and assign investigations to team members, ensuring timely completion according to guidelines.
• Collaborate with stakeholders to determine if corrective actions effectively address root causes of non-conformance events.
• Identify and implement process improvements related to safety, quality, compliance, and productivity.
• Serve as a project manager for the change control process and ensure regulatory compliance.
• Act as a Subject Matter Expert (SME) during internal and external regulatory audits including FDA and EMEA.
• Review and approve SOPs and batch record revisions.

Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• 3 years of experience as a Lead Engineer.
• Proficiency in eLIMS, TrackWise, Maximo, EMS, BMS, and SAP systems.
• Ability to work onsite in Raritan, NJ.
• Strong understanding of regulatory compliance and quality management systems.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with company match vesting on day one.
• Eight weeks of paid parental leave after three months of employment.
• Generous paid time off policy including vacation, personal, sick time, and eleven company holidays.
• Access to family planning resources, well-being initiatives, and peer-to-peer recognition programs.