Site Regulatory Compliance Director – Advanced Therapy

Johnson & Johnson; Horsham (PA); On-site; USD 150,000 - 259,000; Full time

Benefits offered by this job

Vacation

Sick time

Holiday pay

Parental Leave

Long-term incentive program

Job summary

Johnson & Johnson is seeking a Director, Regulatory Compliance to lead site-based compliance at a multi-site Advanced Therapy manufacturing setting (Raritan, NJ; Horsham, PA; Malvern, PA). You will drive inspection readiness, risk assessments, and governance across Quality, Manufacturing, MSAT, and Regulatory Affairs.

You will coach leaders, develop a high-performing team, and promote a culture of transparency and continuous improvement while ensuring regulatory alignment for autologous and

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 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.

Responsibilities

• Provide strategic site compliance leadership and independent regulatory compliance perspective on site inspection readiness and regulatory risk.
• Drive enterprise thinking and organizational capability to connect site risks to enterprise risks.
• Provide an independent regulatory compliance perspective on the site compliance-risk posture and support visibility, prioritization, escalation, and governance.
• 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.
• Develop succession plans and foster an inclusive, accountable, and high-performing culture.

Skills

Agile Internal Audit

Analytical Reasoning

Regulatory Compliance

Risk Management

Quality Auditing

Quality Control

Leadership

Stakeholder Management

Audit Trends

Compliance Policies

Education

Bachelor's degree required

Advanced degree preferred

Job description

Johnson & Johnson is seeking a Director, Regulatory Compliance to lead site-based compliance at a multi-site Advanced Therapy manufacturing setting (Raritan, NJ; Horsham, PA; Malvern, PA). You will drive inspection readiness, risk assessments, and governance across Quality, Manufacturing, MSAT, and Regulatory Affairs.

You will coach leaders, develop a high-performing team, and promote a culture of transparency and continuous improvement while ensuring regulatory alignment for autologous and