The position ensures effective implementation and performance of the Nijmegen Quality Management System in line with regulatory and internal requirements, strengthens operational discipline and assured customer supply, ensures inspection and audit readiness, builds organizational capability and creates the conditions for successful capacity expansion.
Key Accountabilities
Site strategy and enterprise leadership
Own the site strategic plan, annual business plan, operating priorities, governance and performance rhythm.
Lead the Site Leadership Team, clarify decision rights and ensure effective cross-functional execution and escalation.
Partner with and drive supporting functions (Quality, Engineering, Maintenance, HR, Finance, Planning and EHS&S) to ensure execution, compliance and accurate reporting.
Represent Nijmegen in network, investment and portfolio discussions, clearly articulating site capabilities, risks and opportunities.
Safety, quality and compliance
Ensure full compliance with applicable laws, regulations, quality-system requirements, company policies and Health, Safety and Environmental standards.
Build and sustain a culture in which product quality, patient safety, data integrity and employee safety are non-negotiable.
Maintain continuous inspection and audit readiness, with strong oversight of CAPAs, nonconformances, validation, training and remediation commitments.
Ensure the Nijmegen Quality Management System is effectively implemented and performing in line with ISO 13485, EU MDR, FDA 21 CFR Part 820, MDSAP and Johnson & Johnson requirements, with regular audits and timely preventive and corrective actions.
Act as senior site management during regulatory inspections and ensure timely, transparent and effective resolution of observations.
Operational performance and reliable supply
Own overall site performance across safety, quality, delivery, cost, inventory, productivity and people metrics.
Ensure reliable production and release through robust planning, tiered accountability, risk management and disciplined problem solving.
Drive manufacturing excellence, process repeatability, right-first-time execution, yield improvement and sustainable cost performance.
Use dashboards, control charts and tiered performance indicators to take timely action where results deviate from controls or targets.
Reduce critical defects, field issues and waste, and drive cost improvement projects through Lean, Six Sigma and Process Excellence.
Balance near-term delivery with long-term capability, maintenance, calibration, engineering and lifecycle-management needs.
Growth, scale-up and transformation
Lead site readiness for capacity expansion and future volume growth, ensuring facilities, equipment, systems, processes and organization mature together.
Provide executive sponsorship for critical capital, validation, technology-transfer and operational-readiness programs.
Ensure investment proposals are supported by clear capacity models, business cases, resource plans, milestones and risk controls.
Lead change with a strong focus on business continuity, stakeholder alignment and adoption.
Financial and business stewardship
Own the site budget and financial performance, including operating expense, capital investment, productivity and headcount plans.
Build and maintain multi-year financial and resource plans that support supply, compliance and growth commitments.
Make fact-based trade-offs, manage risks proactively and ensure resources are focused on the highest-value and most critical priorities.
Ensure appropriate controls, governance and transparency in business and project reporting.
People, culture and organization
Build a high-performing, inclusive and accountable site culture grounded in Our Credo, the Johnson & Johnson Leadership Imperatives and ethical leadership.
Design and develop the organization required for current operations and future scale, including succession, workforce and capability planning.
Lead managers and senior individual contributors in a matrix environment, with accountability for career development, regular coaching and feedback, and "ready now" succession plans for key positions.
Attract, onboard, coach and retain strong leaders and technical talent; set clear expectations and address performance issues promptly and fairly.
Engage employees through visible leadership, clear communication, listening and recognition.
Decision Rights and Measures of Success
Safety and compliance: No compromise on safety or quality; sustained inspection readiness; timely closure of commitments and systemic risk reduction.
Customer and supply: Reliable plan attainment, predictable release and service performance, with effective recovery when disruptions occur.
Operations: Improved right-first-time, yield, productivity, schedule adherence and asset reliability.
Growth: Expansion milestones achieved with controlled risk, operational continuity and demonstrated readiness.
Financial: Delivery of budget, capital and productivity commitments with transparent forecasting and controls.
Organization: Critical roles staffed, succession depth strengthened, engagement supported and leadership capability measurably improved.
Experience and Education
Bachelor's degree in engineering, science, operations, supply chain or another relevant discipline; an advanced degree is preferred.
10+ years of progressive experience in regulated manufacturing, preferably medical devices, pharmaceuticals, biotechnology or life sciences, including at least 3 years in senior operations leadership roles.
Proven experience as the accountable leader of a manufacturing site, operations business unit or complex multi-functional operation, with full profit-and-loss, budget, quality and people responsibility and leadership of managers and senior leaders.
Strong tenure and career stability, with a history of seeing major programs and organizational changes through to completion.
Proven record of leading through scale-up, transformation, capacity expansion, technology transfer or significant compliance improvement, with successful and sustained outcomes.
Demonstrated, measurable performance outcomes, such as an inspection and audit record without critical findings, reliable supply, improved yield and productivity, delivery of cost and capital commitments, and stronger organizational capability.
Experience interacting with health authorities, notified bodies, inspectors or external auditors is strongly preferred.
Extensive knowledge of ISO 13485, ISO 14971, EU MDR, FDA 21 CFR Part 820 and MDSAP regulations and standards, including experience with quality-system audits by major regulatory bodies.
Lean or Six Sigma certification is recommended; proficiency in the Microsoft Office suite and company quality and training systems.
Fluent written and spoken English. Dutch language capability is an advantage but not essential.
Required Leadership Capabilities
Strategic and enterprise mindset: Sets a clear site vision and turns network and business priorities into an executable multi-year plan, balancing near-term delivery with long-term capability.
Integrity and quality leadership: Models Our Credo and treats patient safety, product quality, data integrity and employee safety as non-negotiable.
Accountability and operational discipline: Owns site performance across safety, quality, delivery, cost, inventory and people metrics, using tiered accountability, risk management and data-driven problem solving.
Leading change and scale-up: Leads transformation and capacity expansion while protecting business continuity and ensuring stakeholder alignment and adoption.
Influence and collaboration in a matrix: Builds trust and alignment across the Site Leadership Team, supporting functions and network partners.
Talent development and visible leadership: Attracts, coaches and retains strong leaders, builds succession depth, addresses performance fairly, and engages employees through a strong onsite presence and clear communication.
Resilience under pressure: Stays calm and decisive during inspections, incidents and supply disruptions.
Regulatory credibility and external engagement: Engages transparently with health authorities, notified bodies and auditors, and represents Nijmegen credibly in network and investment discussions.
Additional Position Requirements
Primary work location is the Johnson & Johnson site in Nijmegen. The role is expected to maintain a strong and visible onsite presence.
Expected travel of up to 10% (domestic and international) to support network, supplier and business needs.
The role may require availability outside standard working hours to support critical operations, inspections, incidents or business continuity.
Reasonable accommodations may be made to enable qualified individuals to perform the essential functions of the role. Company management reserves the right to add, delete or alter assigned duties at any time.
Relocation support may be provided for qualified candidates in accordance with company policy.
Required Skills
Preferred Skills
The anticipated base pay range for this position is
€102,500.00 - €177,445.00
Benefits
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.
Additional information
The Netherlands: 8%.The annual base pay includes an 8% holiday allowance.
Het bruto jaarsalaris is inclusief vakantietoeslag van 8%.
