QA Investigations Lead (Biotech)

TL;DR

QA Investigations Lead (Biotech): Providing quality oversight and guidance during the investigation of events in the production of personalized cell therapy products with an accent on GMP compliance and root cause analysis. Focus on ensuring timely investigation closure, developing robust CAPAs, and supporting regulatory inspections within a sterile manufacturing environment.

Location: Must be based in Raritan, New Jersey (Hybrid role)

Salary: $68,045–$109,870 USD

Company

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

What you will do

• Ensure timely completion of high-quality investigations with robust root cause analysis.
• Develop and implement effective Corrective and Preventative Actions (CAPAs).
• Support regulatory inspections and audits as a subject matter expert.
• Collaborate with manufacturing and operations teams to resolve end-to-end production issues.
• Maintain and review manufacturing investigations, change controls, and complaints.
• Analyze quality data to identify trends and support process improvement initiatives.

Requirements

• Bachelor’s Degree in Science, Engineering, or equivalent technical discipline.
• 2-4 years of relevant work experience, preferably in aseptic manufacturing or quality assurance.
• Strong knowledge of cGMP and GDP regulations and FDA/EU guidance for cell-based products.
• Excellent organizational, communication, and presentation skills.
• Ability to interpret complex problems and determine resolutions that minimize risk.
• Strong leadership skills with the ability to develop others and manage conflict.

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, sick time, and eleven company holidays.
• Access to well-being initiatives, family planning resources, and voluntary supplemental insurance plans.