Director, External Manufacturing Regulatory Compliance Oversight (MedTech)

Location: US Johnson & Johnson Sites, including Horsham and Malvern, Pennsylvania, and New Brunswick, Raritan, and Spring House, New Jersey/Pennsylvania. Hybrid role with up to 25–40% global travel.

Base pay: $150,000–$258,750 per year.

Company

hirify.global develops healthcare solutions and medical technologies designed to improve patient outcomes.

What you will do

• Provide independent regulatory compliance oversight across contract manufacturers, contract laboratories, sterilization providers, critical suppliers, and strategic partners.
• Identify emerging compliance risks, recurring observations, inspection-readiness concerns, and systemic vulnerabilities.
• Support mock inspections, health authority inspections, remediation reviews, regulatory commitments, and inspection responses.
• Assess CAPA effectiveness, root-cause analyses, preventive actions, and the sustainability of remediation programs.
• Prepare risk assessments, trend analyses, regulatory intelligence, and recommendations for governance forums and leadership.
• Lead, coach, and develop compliance professionals while partnering with Quality, Supply Chain, Procurement, Regulatory Affairs, and Technical Operations.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related scientific discipline; an advanced degree is preferred.
• At least 12 years of pharmaceutical, biotechnology, biologics, advanced therapy, medical device, or combination product GMP experience.
• At least 5 years of leadership experience in Quality, Compliance, Regulatory Compliance, Supplier Quality, or External Manufacturing.
• Experience with health authority inspections, remediation programs, CMO oversight, inspection readiness, CAPA governance, risk management, and quality systems.
• Strong knowledge of global GMP regulations, supplier quality management, risk-based oversight, and pharmaceutical quality systems.
• Ability to influence without direct authority, communicate complex compliance risks, and work effectively in global, highly matrixed environments.

Culture & Benefits

• Inclusive work environment guided by the company’s Credo and commitment to diversity and dignity.
• Retirement pension and 401(k) savings plans.
• Long-term incentive program eligibility.
• Vacation, sick time, holidays, parental, bereavement, caregiver, volunteer, and military spouse leave programs.
• Global collaboration with opportunities to influence compliance performance across an external manufacturing network.