Dir External Manufacturing Regulatory Oversight

• Switzerland - Requisition Number: R-099845
• Independent challenge

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, and solutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Legal & Compliance

Job Sub Function

Enterprise Compliance

Job Category

People Leader

All Job Posting Locations

Beerse, Antwerp, Belgium, Latina, Italy, Leiden, South Holland, Netherlands, Sassenheim, Netherlands

Job Description

Director, External Manufacturing Regulatory Compliance Oversight

Location: EU Johnson & Johnson Sites

Reports To: Senior Director, External Manufacturing Regulatory Compliance Oversight

Travel- Up to 25-40% (Global)

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

• Belgium, Italy, Netherlands - Requisition Number: R-099404
• Switzerland - Requisition Number: R-099845

Position Summary

The Director, External Manufacturing Regulatory Compliance Oversight, provides independent regulatory compliance oversight, risk visibility, inspection-readiness support, governance, and organizational learning across the Innovative Medicine External Manufacturing network. The role partners with External Manufacturing Operations, Quality, Supply Chain, Procurement, Regulatory Affairs, Technical Operations, and other stakeholders to identify emerging compliance risks, strengthen compliance performance, and support proactive risk management across contract manufacturers, contract laboratories, strategic partners, and other external suppliers. This role operates within the External Manufacturing Regulatory Compliance Oversight organization and supports implementation of the compliance oversight strategy established for the network. The Director provides independent assessments, compliance challenge, and risk-based recommendations to improve regulatory compliance, inspection readiness, and remediation effectiveness. The role supports the broader IMRC mission of increasing risk visibility, strengthening governance, preventing recurrence of significant observations, and ensuring lessons learned are effectively deployed across the external manufacturing network.

Mission

Strengthen regulatory compliance across the External Manufacturing network through proactive, risk-based oversight, independent assessment of compliance risks, inspection-readiness support, remediation effectiveness oversight, and deployment of organizational learning that improves compliance performance across external partners.

Key Responsibilities

Risk Visibility, Oversight & Escalation

• Monitor and assess significant compliance risks across assigned external manufacturing partners.
• Identify emerging risk signals, recurring observations, inspection readiness concerns, and remediation trends.
• Conduct independent risk assessments and provide objective compliance challenge to accountable functions.
• Support escalation and governance processes for significant compliance risks.
• Evaluate recurring observations and compliance trends to identify systemic vulnerabilities requiring broader action.
• Provide compliance insights and recommendations to leadership and governance forums. Based on the Senior Director's responsibility for enterprise risk visibility and escalation.

Inspection Readiness & Health Authority Oversight

• Provide independent oversight and challenge of inspection readiness activities across assigned external manufacturing partners.
• Support readiness reviews, mock inspections, and risk-based assessments.
• Participate in regulatory inspection support