Dir External Manufacturing Regulatory Oversight

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 96 000 - 280 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson is seeking a Director of External Manufacturing Regulatory Compliance Oversight to strengthen regulatory compliance across its External Manufacturing network. The role focuses on independent risk assessment, inspection readiness, and governance across global partners.

The position requires extensive GMP knowledge, leadership in quality/compliance, and experience with Health Authority inspections, CAPA governance, and risk management. Travel up to 25-40% is anticipated.

Qualifications

• Education: Bachelor's Degree in Life Sciences, Engineering, Pharmacy, or related field; Advanced degree preferred.
• Leadership experience: minimum 5 years in Quality, Compliance, Regulatory Compliance, or External Manufacturing.
• Experience with Health Authority inspections, remediation programs, and supplier oversight.

Responsabilités

• Provide independent oversight of regulatory compliance across External Manufacturing network.
• Support inspection readiness activities and regulator interactions.
• Assess oversight of CMOs, CDMOs, and critical external partners; review CAPAs and risk management.
• Lead governance forums, share regulatory intelligence, and drive continuous improvement.

Connaissances

Regulatory compliance

GMP knowledge

Leadership

Risk management

Executive communication

Formation

Bachelor's Degree in Life Sciences

Advanced degree preferred

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

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)

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.

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.

Preferred Skills

• The anticipated pay range for this position, in the primary posting location, is:
• Italy– The anticipated base pay range for this position is 95,900 – 165,370
• Netherlands – The anticipated base pay range for this position is 160,000 – 280,485

Compensation & Benefits

The anticipated pay range for this position, in the primary posting location, is:

Italy– The anticipated base pay range for this position is 95,900 – 165,370

Netherlands – The anticipated base pay range for this position is 160,000 – 280,485

• in addition to base pay, we offer the following benefits*: an annual bonus 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.
• The Netherlands: The annual base pay includes an 8% holiday allowance.

About Johnson & Johnson

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/.