Sr. Specialist, Quality Systems (Biotech)

Location: Pennington, New Jersey, United States

Salary: $70,000–$90,000 per year, based on skills and experience.

Company

hirify.global is a biotechnology company providing research and development services and products, with ProBio offering end-to-end CDMO services for plasmids, antibodies, and cell and gene therapies.

What you will do

• Maintain and continuously improve ProBio quality management systems for clinical and commercial cell and gene therapy products.
• Review and approve documentation for change controls, CAPAs, deviations, laboratory investigations, complaints, incidents, exceptions, and OOS reports.
• Facilitate root cause analysis and investigations, track overdue actions, and verify CAPA effectiveness.
• Develop and monitor quality metrics and KPIs, analyze trends, and prepare management review reports.
• Participate in customer, regulatory, and internal audits and coordinate responses to findings.
• Maintain inspection readiness and support a culture of quality and operational excellence.

Requirements

• Bachelor’s degree in a scientific discipline and 3+ years of experience in QA or a related role in pharmaceutical, biotechnology, or a similar environment.
• Experience with GxP document management systems or QMS platforms such as Veeva QualityDocs, Veeva QMS, or TrackWise QMS.
• Knowledge of GxP document control, change control, CAPA, deviations, laboratory investigations, GMP regulations, and compliance requirements.
• In-depth knowledge of quality risk management, root cause analysis, and investigation tools.
• Understanding of biologics manufacturing and laboratory activities.
• Strong communication, analytical, planning, organization, time management, and problem-solving skills; ability to work independently and collaboratively in a fast-paced matrixed environment.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Paid parental leave after three months of employment.
• Paid vacation, personal, sick, floating holiday, and company holiday time.
• Flexible spending and health savings accounts, life and disability insurance, legal assistance, and supplemental insurance plans.
• Commuter benefits, well-being initiatives, and peer-to-peer recognition programs.