Associate Director, Site Quality Compliance Lead (Biotech)

TL;DR

Associate Director, Site Quality Compliance Lead (Biotech): Managing and driving the regulatory compliance process within a cell therapy manufacturing facility with an accent on GxP standards, inspection readiness, and audit management. Focus on overseeing quality systems, mitigating risks in a sterile GMP environment, and ensuring alignment with global regulatory expectations.

Location: Bridgewater, New Jersey, United States

Salary: $168,372 - $220,988 USD

Company

hirify.global is a global biotechnology company dedicated to treating and curing life-threatening diseases through advanced cell therapies.

What you will do

• Provide strategic direction for site quality compliance programs, aligning with global regulations and J&J expectations.
• Lead regulatory inspections and independent audits, including front-room and back-room coordination.
• Oversee compliance health monitoring, risk assessments, and the effectiveness of CAPAs and change controls.
• Maintain site-specific quality documents, SOPs, and the Site Master File (SMF).
• Manage resources and projects within a highly matrixed organization through influence.
• Coordinate internal audits, self-inspections, and GEMBA walk programs.

Requirements

• Bachelor’s degree in a scientific or technical discipline (advanced degree preferred).
• Minimum 12 years of GxP experience in Quality, Regulatory, or related functions.
• Minimum 5 years of leadership experience, specifically leading through influence in matrixed organizations.
• Experience in aseptic manufacturing, biologics, or advanced therapies (cell therapy).
• Deep expertise in global GxP regulations (21 CFR, ICH, EU GMP, etc.).
• Proven experience hosting regulatory inspections and conducting internal audits.

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 11 company holidays.
• Additional benefits: FSA, HSA, life insurance, and legal assistance.