Associate Director, GxP Compliance and Auditing (Biotechnology)

Location: Bridgewater, New Jersey, United States; hybrid role with on-site travel to Somerset and Raritan CARVYKTI manufacturing facilities. Applicants must be authorized to work in the United States.

Salary: $168,372–$220,988 USD per year, plus performance-based bonus and/or equity for eligible roles.

Company

hirify.global is a global commercial-stage biotechnology company developing cell therapy platforms, including CAR-T, CAR-NK, CAR-γδ T, and other therapies for serious diseases.

What you will do

• Lead global GxP compliance and auditing programs and own related business processes, systems, procedures, training, and quality governance.
• Drive inspection readiness, host and support health authority inspections, and manage responses to audit and inspection observations.
• Lead internal audits at Somerset and Raritan CARVYKTI sites and oversee external, supplier, vendor, and third-party audits.
• Oversee supplier qualification, risk assessments, audit schedules, audit reports, CAPAs, and regulatory responses.
• Manage regulatory intelligence, quality management reviews, quality metrics, risk assessments, and quality planning.
• Partner with Quality, Manufacturing, suppliers, CROs, CMOs, and global sites to strengthen compliance culture and cross-site alignment.

Requirements

• Bachelor’s degree in a scientific or technical discipline; an advanced degree is preferred.
• At least 12 years of relevant GxP experience and at least 5 years of leadership experience in biopharmaceuticals or advanced therapies.
• Experience conducting internal audits, hosting external audits and regulatory inspections, and leading enterprise-level compliance programs.
• Deep knowledge of global GxP regulations and quality frameworks, including 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA, and China GMP Regulations.
• Experience with regulatory intelligence, quality metrics, electronic quality systems, digital compliance tools, and IT system development lifecycles.
• 20% travel is required, and United States work authorization is required.

Nice to have

• Experience in aseptic manufacturing, biologics, advanced therapies, or cell therapy.
• Experience across GMP, GDP, GCP, and GLP functions.
• Experience managing direct reports and working in a matrixed organization.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance.
• Benefits include a 401(k) plan with a company match, paid parental leave, paid time off, and company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, and family care resources.
• The role supports a patient-first, innovation-driven, results-focused culture emphasizing integrity, teamwork, ownership, and continuous improvement.