19 set - Latina
Johnson & Johnson
Switzerland - Requisition Number: R-******
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 *****% (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
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-******
Switzerland - Requisition Number: R-******
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 activities before, during, and after inspections.
Review regulatory commitments, remediation plans, and inspection responses for adequacy and sustainability.
Monitor implementation of actions associated with significant inspection observations.
Facilitate deployment of inspection learnings and best practices across the network.
External Manufacturing Compliance Oversight
Provide independent compliance oversight of contract manufacturers, contract laboratories, external sterilization providers, critical suppliers, and strategic partners.
Assess whether oversight approaches appropriately reflect partner risk, product complexity, regulatory history, and business criticality.
Review compliance trends related to inspections, deviations, complaints, investigations, CAPAs, and supplier performance.
Challenge the adequacy of risk mitigation plans and remediation strategies.
Support compliance evaluations associated with new partnerships, technology transfers, product launches, and network changes.
CAPA Effectiveness & Recurrence Prevention
Provide independent oversight of corrective and preventive actions arising from inspections, audits, supplier assessments, and significant quality events.
Evaluate effectiveness verification activities and sustainability of remediation efforts.
Assess root cause analyses for completeness and identification of systemic contributors.
Identify repeat observations and recurring compliance issues requiring broader intervention.
Support development of preventive actions designed to mitigate recurrence across multiple partners and products.
Governance, Regulatory Intelligence & Organizational Learning
Support governance forums through preparation of risk assessments, trend analyses, and compliance recommendations.
Monitor external regulatory trends, warning letters, inspection observations, and emerging expectations impacting outsourced manufacturing.
Translate regulatory intelligence into actionable insights and compliance recommendations.
Support deployment of lessons learned across the External Manufacturing network.
Contribute to development of standards, tools, playbooks, and best practices that strengthen compliance oversight and inspection readiness.
Cross-Functional Collaboration & Influence
Partner with:
External Manufacturing Operations
Supply Chain
Procurement
Quality
Regulatory Affairs
Product Development
Technical Operations
Manufacturing Science & Technology
Influence compliance outcomes through strong partnerships and effective risk communication.
Provide independent compliance perspectives that support informed decision-making and effective risk management.
Promote transparency, accountability, and early escalation of compliance concerns.
People Leadership
Lead, coach, and develop compliance professionals supporting External Manufacturing oversight activities.
Promote a culture focused on:
Proactive risk identification
Independent challenge
Inspection readiness
Risk-based decision-making
Accountability
Continuous improvement
Build technical capabilities in external manufacturing compliance oversight, regulatory intelligence, CAPA effectiveness, and risk assessment.
Adapted from the Senior Director people leadership expectations while reducing organizational ownership.
Required Qualifications
Education
Bachelor's Degree in Life Sciences, Engineering, Pharmacy, or related scientific discipline.
Advanced degree preferred.
Experience
Minimum 12 years of pharmaceutical, biotechnology, biologics, advanced therapy, medical device, or combination product GMP experience.
Minimum 5 years of leadership experience in Quality, Compliance, Regulatory Compliance, Supplier Quality, or External Manufacturing.
Experience supporting Health Authority inspections, remediation programs, and supplier oversight activities.
Demonstrated experience with CMO oversight, inspection readiness, CAPA governance, risk management, and quality systems.
Experience working in global and highly matrixed environments.
Knowledge, Skills & Capabilities
Strong understanding of global GMP regulations and external manufacturing compliance requirements.
Knowledge of pharmaceutical quality systems, supplier quality management, inspection readiness, and risk-based oversight approaches.
Ability to identify and communicate complex compliance risks in a clear and actionable manner.
Strong analytical, problem-solving, and decision-support capabilities.
Ability to influence without direct authority across a global network.
Strong executive communication and stakeholder engagement skills.
Ability to balance independent oversight with productive cross-functional partnerships.
Benefits
In addition to base pay, we offer the following benefits*: an annual premio with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions.
Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health.
We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans.
For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
This is for informative purposes only.
Amounts and actual benefits may vary by location and are subject to change.
Additional Information
The Netherlands: The annual base pay includes an 8% holiday allowance.
Pay Range
Italy– The anticipated base pay range for this position is 95,*********,370
Netherlands – The anticipated base pay range for this position is 160,*********,485
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