Director, Site Regulatory Compliance – Advanced Therapy

Johnson & Johnson; Malvern (Chester County); On-site; USD 150,000 - 259,000; Full time

Benefits offered by this job

Long-term incentive program

Vacation 120 hours/year

Sick time 40 hours/year

Job summary

Johnson & Johnson seeks a Director, Site Regulatory Compliance to lead independent regulatory oversight at an Advanced Therapy manufacturing site in the U.S. The role partners with Quality, Manufacturing, MSAT, and Regulatory Affairs to ensure inspection readiness and robust risk governance.

Ideal candidates have 10+ years in pharma/biotech, strong leadership, and deep knowledge of biologics, GMP, and cell therapy regulatory expectations. Travel 10–25% may be required.

Qualifications

• Bachelor’s degree in Biotechnology, Biological Sciences, Pharmacy, Engineering, Microbiology, Chemistry, or related scientific discipline is required.
• 10+ years of pharmaceutical or biotechnology experience.
• 5+ years of leadership experience.
• Significant experience in biologics manufacturing operations, quality, compliance, or regulatory oversight.
• Experience supporting FDA, EMA, MHRA, or PMDA inspections and other global health authority inspections.
• Knowledge of cell therapy manufacturing, including autologous and allogeneic operations.
• Knowledge of GMP regulations and Advanced Therapy regulatory expectations.
• Knowledge of chain of identity and chain of custody controls.
• Knowledge of aseptic processing, data integrity, process validation, and quality systems.
• Knowledge of inspection readiness, regulatory risk assessment, governance, escalation, and organizational learning.
• Strong communication, influencing, people-leadership, and cross-functional partnership skills.
• This position may require 10% to 25% domestic and/or international travel.

Responsibilities

• Provide strategic site compliance leadership and independent regulatory compliance perspective on site inspection readiness and regulatory risk, product launch readiness and technology transfers, capacity expansion and facility modifications, major deviations, quality events, and data integrity concerns.
• Drive enterprise thinking and organizational capability to connect significant site risks to platform and enterprise risks, promote consistent risk identification, escalation, and cross-site learning.
• Provide an independent regulatory compliance perspective on the site compliance-risk posture and support effective visibility, prioritization, escalation, and governance of significant risks.
• Provide independent oversight of continuous inspection readiness in partnership with Site Quality and accountable functions.
• Provide compliance leadership for Advanced Therapy manufacturing operations.
• Lead, coach, and develop Site-Based Regulatory Compliance staff.

Skills

Leadership

Regulatory compliance

Communication

Cross-functional

Strategic thinking

Risk assessment

Auditing

Travel readiness

Education

Bachelor's degree in Biotechnology, Biological Sciences, Pharmacy, Engineering, Microbiology, Chemistry, or related scientific discipline

Advanced degree preferred

Job description

Johnson & Johnson seeks a Director, Site Regulatory Compliance to lead independent regulatory oversight at an Advanced Therapy manufacturing site in the U.S. The role partners with Quality, Manufacturing, MSAT, and Regulatory Affairs to ensure inspection readiness and robust risk governance.

Ideal candidates have 10+ years in pharma/biotech, strong leadership, and deep knowledge of biologics, GMP, and cell therapy regulatory expectations. Travel 10–25% may be required.