Quality Manager - GMP Analytical Testing Site

Location: Lebanon, NJ, United States; onsite Monday through Friday, 8:30 AM–5:00 PM

Salary: $115,000–$135,000 per year, plus annual bonus opportunity

Company

hirify.global Life Sciences provides contract CMC development, clinical trial manufacturing, regulatory compliance, consulting, and facility support services for pharmaceutical, biopharmaceutical, and gene therapy industries.

What you will do

• Manage and maintain the Quality Management System and report critical quality KPIs.
• Oversee QA activities for analytical laboratory operations and GMP testing.
• Review and approve analytical documentation, protocols, reports, investigations, and quality records.
• Lead internal audits, inspection readiness, client audits, regulatory inspections, and supplier audits.
• Support method validation, method transfer, stability studies, analytical development, regulatory filings, and quality agreements.
• Lead and develop the Quality Assurance team while driving quality metrics and continuous improvement.

Requirements

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• 7+ years of Quality Assurance experience in a pharmaceutical, biotechnology, CDMO, or contract analytical laboratory environment.
• 3+ years of leadership or people management experience.
• Strong knowledge of FDA regulations, cGMP requirements, ICH guidelines, data integrity, and laboratory compliance programs.
• Experience managing deviations, CAPAs, change controls, and investigations.
• Excellent written, verbal, organizational, and interpersonal communication skills.

Nice to have

• Advanced degree in a scientific discipline.
• Experience with analytical outsourcing services or contract testing laboratories.
• Experience with electronic quality management systems.
• Experience supporting client audits and FDA inspections.

Culture & Benefits

• Collaborative and science-driven work environment.
• Medical, dental, and vision coverage.
• 401(k) retirement savings plan with company match.
• Paid holidays, sick leave, vacation, and other paid time off.
• Professional development, career growth, tuition reimbursement, wellness program, HSA, FSA, parental leave, and employee assistance program.
• Work performed in laboratory and office environments with exposure to chemicals, fumes, gases, and related laboratory hazards.