Strategic Site Regulatory Compliance Director

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

Benefits offered by this job

Vacation hours

Sick time

Holiday pay

Work, Personal and Family Time

Parental Leave

Bereavement Leave

Caregiver Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson is seeking a Director of Site Regulatory Compliance in the U.S. to lead independent regulatory oversight at an Advanced Therapy site.

You will partner with site leadership and cross-functional teams to ensure inspection readiness and robust risk management across biologics operations. The role emphasizes leadership of the regulatory compliance function, knowledge of autologous and allogeneic therapies, and the ability to drive governance and continuous improvement across the

Qualifications

• Bachelor’s degree in Biotechnology, Biological Sciences, Pharmacy, Engineering, Microbiology, Chemistry, or related field is required.
• 10+ years of pharmaceutical/biotech experience.
• 5+ years of leadership experience.
• Experience with FDA/EMA/MHRA/PMDA inspections.
• Knowledge of GMP and advanced therapy regulatory expectations.

Responsibilities

• Provide strategic site compliance leadership and independent regulatory perspective on readiness and risk.
• Connect site risks to platform and enterprise risks and promote learning.
• Oversee compliance for Advanced Therapy manufacturing operations.
• Lead, coach, and develop Site-Based Regulatory Compliance staff.

Skills

Regulatory Compliance

Leadership

Quality Auditing

Risk Management

Stakeholder Management

Analytical Reasoning

Third-Party Auditing

Tactical Planning

Developing Others

Compliance Policies

Education

Bachelor's degree in Biotechnology/Related

Job description

Johnson & Johnson is seeking a Director of Site Regulatory Compliance in the U.S. to lead independent regulatory oversight at an Advanced Therapy site.

You will partner with site leadership and cross-functional teams to ensure inspection readiness and robust risk management across biologics operations. The role emphasizes leadership of the regulatory compliance function, knowledge of autologous and allogeneic therapies, and the ability to drive governance and continuous improvement across the