Director, Site Regulatory Compliance (Advanced Therapy)

Location: Raritan, New Jersey; Horsham, Pennsylvania; or Malvern, Pennsylvania, United States. The role may require 10%–25% domestic and/or international travel.

Base pay: $150,000–$258,750 per year.

Company

Johnson & Johnson MedTech develops healthcare solutions and advanced therapies across the spectrum of medicine.

What you will do

• Provide independent regulatory compliance leadership for site inspection readiness, regulatory risk, product launches, technology transfers, facility changes, deviations, quality events, and data integrity concerns.
• Oversee compliance risk visibility, prioritization, escalation, governance, and connection of site risks to platform and enterprise priorities.
• Lead continuous inspection readiness for advanced therapy manufacturing, including aseptic processing, patient-specific controls, chain of identity and custody, electronic records, and cryogenic storage and transportation.
• Support compliance leadership across autologous and allogeneic operations, validation, manufacturing execution systems, comparability, and multi-site lifecycle controls.
• Lead, coach, and develop site-based regulatory compliance staff.
• Build succession plans and strengthen an inclusive, accountable, high-performing compliance culture.

Requirements

• Bachelor’s degree in biotechnology, biological sciences, pharmacy, engineering, microbiology, chemistry, or a related scientific discipline; an advanced degree is preferred.
• 10+ years of pharmaceutical or biotechnology experience and 5+ years of leadership experience.
• Significant experience in biologics manufacturing operations, quality, compliance, or regulatory oversight.
• Experience supporting FDA, EMA, MHRA, PMDA, and other global health authority inspections.
• Knowledge of cell therapy manufacturing, GMP regulations, chain of identity and custody, aseptic processing, data integrity, process validation, and quality systems.
• Strong communication, influencing, people-leadership, and cross-functional partnership skills.

Nice to have

• Advanced degree in a relevant scientific or engineering discipline.
• Experience with regulatory risk assessment, governance, escalation, organizational learning, and inspection-readiness capability building.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, transparency, and accountability.
• Participation in pension and 401(k) savings plans, subject to plan terms.
• Eligibility for a long-term incentive program.
• Vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, volunteer leave, and other paid time-off benefits.