Senior Director, External Manufacturing Regulatory Compliance

Location: Horsham, Malvern, Spring House, Pennsylvania, or New Brunswick and Raritan, New Jersey, United States

Base pay: $178,000–$307,050 per year

Company

Johnson & Johnson MedTech develops healthcare solutions and medical technologies across the spectrum of prevention, treatment, and patient care.

What you will do

• Lead enterprise regulatory compliance oversight for the Innovative Medicine external manufacturing network.
• Develop risk-based oversight strategies for contract manufacturers, laboratories, suppliers, sterilization providers, and strategic partners.
• Maintain visibility of significant compliance risks, inspection-readiness concerns, remediation themes, and emerging regulatory signals.
• Provide independent compliance perspectives on partnerships, acquisitions, technology transfers, product launches, inspections, and network changes.
• Partner with Quality, Supply Chain, Procurement, Regulatory Affairs, Product Development, Technical Operations, and Manufacturing Science & Technology.
• Build governance, organizational learning, escalation, and preventive-action processes across the external manufacturing network.

Requirements

• Bachelor’s degree in life sciences, engineering, pharmacy, or a related field; an advanced degree is preferred.
• At least 15 years of pharmaceutical, biotechnology, biologics, advanced therapy, medical device, or combination-product GMP experience.
• At least 10 years of leadership experience in Quality, Compliance, Regulatory Compliance, External Manufacturing, or supplier oversight.
• Experience leading global compliance or oversight programs involving external manufacturing partners and supporting major regulatory inspections and complex remediation.
• Strong knowledge of pharmaceutical quality systems, supplier quality management, risk-based oversight, inspection readiness, CAPA governance, deviation management, and enterprise governance.
• Ability to influence without direct authority, communicate complex compliance risks clearly, and lead in a highly matrixed global environment.

Nice to have

• Experience interacting with global Health Authorities.
• Advanced degree in a relevant discipline.
• Experience with regulatory intelligence, audit trends, compliance policy development, and inclusive leadership.

Culture & Benefits

• Inclusive work environment grounded in the company’s Credo and commitment to diversity and dignity.
• Participation in a consolidated retirement plan, pension, savings plan, and 401(k).
• Eligibility for the long-term incentive program.
• Paid vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time-off.