Investigations Supervisor (Biotechnology)

Location: Onsite in Raritan, New Jersey, United States. Applicants must be authorized to work in the United States and complete Form I-9 and E-Verify verification.

Base pay: $110,706–$145,303 USD per year, plus performance-based bonus and/or equity for eligible roles.

Company

hirify.global is a biotechnology company developing cell therapies, including CAR-T, TCR-T, and natural killer cell-based treatments.

What you will do

• Coordinate investigation assignments, monitor completion, and support timely resolution of deviations and atypical events.
• Perform complex investigations, identify root causes, assess product quality impact, and train new investigators.
• Evaluate corrective actions and effectiveness checks to confirm that nonconformities are adequately addressed.
• Track deviations, events, and key process parameters; prepare trend reports and support SQC and Annual Product Review data collection.
• Lead change-control projects and coordinate compliant implementation of process improvements affecting safety, quality, compliance, productivity, yield, and cost.
• Serve as a subject matter expert during internal and external FDA and EMEA regulatory audits; review and approve SOP and batch record revisions.

Requirements

• BS or BA in engineering, science, or a similar technical discipline.
• At least six years of relevant professional experience and demonstrated ability to complete complex investigations independently.
• Solid knowledge of cGMP regulations and FDA/EU guidance.
• Experience with internal and external regulatory audits and quality investigation processes.
• Ability to learn and use eLIMS, TrackWise, Maximo, EMS, BMS, SAP, and standard data-entry and word-processing programs.
• English required; authorization to work in the United States required.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid time off includes vacation, personal time, sick time, floating holidays, and eleven company holidays.
• Additional benefits include FSA and HSA accounts, disability and life insurance, commuter benefits, family-care resources, and well-being programs.
• The role routinely involves exposure to and handling of biological materials and hazardous chemicals.