Senior Director CAPA, Escalation

Johnson & Johnson

. Develop and lead a comprehensive quality management strategy integrating CAPA, quality issue management, and process improvements .

Posted 10/14/2026full-timeBeerse • BelgiumSenior💰 €152,900 - €264,385 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Quality Management Systems (QMS) and CAPA processes, with a strong focus on regulatory compliance and continuous improvement strategies. Proven ability to lead diverse global teams, manage complex projects, and effectively communicate with senior stakeholders.

Highest-signal resume keywords

Quality Management Systems (QMS)CAPA ProcessesRegulatory ComplianceProcess Excellence CertificationStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Issue ManagementContinuous Improvement StrategyDocument ManagementChange ControlDeviation ManagementQuality MetricsKPI ImplementationInspection ReadinessGovernance FrameworkOperational Experience

Soft Skills

Exceptional Communication SkillsNegotiation SkillsInterpersonal SkillsPlanning and Organizational SkillsTeam Leadership

Tools & Technologies

Trending ToolsQuality Escalation SystemGxP DocumentationComputerized System Validation

Certifications & Qualifications

Six SigmaLEANDEX Green/Black Belt

Industry Keywords

Innovative MedicineGlobal Matrix EnvironmentManufacturing EnvironmentQuality & ComplianceCross-Functional Collaboration

About the role

Key responsibilities & impact

Develop and lead a comprehensive quality management strategy integrating CAPA, quality issue management, and process improvements
Manage a diverse global team with end-to-end CAPA, Issue Management, Escalation, and Investigation process responsibility
Develop and implement an integrated continuous improvement strategy
Champion investigation improvement initiatives across the network
Own the quality escalation/notification system and technical solutions such as trending tools
Facilitate quality, accountability, and quality culture with business partners and stakeholders
Oversee the Innovative Medicine NC/CAPA quality system and Issue Escalation processes
Lead independent monitoring across NC/CAPA processes to support inspection readiness and CAPA oversight
Establish governance programs to track global NC/CAPA processes and metrics
Provide escalation metrics and trending data to Q&C organizations
Interact with senior leaders regarding compliance status and key risks
Participate in and lead NC/CAPA governance forums
Develop strategic imperatives and functional capabilities
Maintain GxP documentation according to quality standards and local regulatory requirements
Review and report quality management system performance to management
Sponsor process and system projects aligned with the Innovative Medicine Quality System Strategy
Provide strategic leadership and coaching to direct reports while overseeing 35–40 personnel across the Americas, Europe, and ASPAC
Engage in industry forums and initiatives to benchmark best practices and influence standards
Ensure implementation and remediation activities comply with new or revised quality requirements
Establish and oversee a global QMS governance framework
Monitor QMS compliance and effectiveness
Represent the organization in governance forums and audits
Lead quality issue and nonconformance management, escalation, and resolution
Implement and monitor quality metrics and KPIs
Develop and deploy holistic quality processes across multiple functions
Collaborate with R&D, Regulatory Affairs, and Operations
Build and lead a diverse global team and foster a high-performance culture
Provide coaching and strategic direction to direct reports

Requirements

What you’ll need

Bachelor’s Degree in a relevant scientific or technical field
Minimum of 15 years of experience in Quality Management Systems (QMS), Operations Management, regulatory compliance, or a related field
Strong knowledge of CAPA processes
Experience supporting Quality & Compliance organizations on management systems
Experience collaborating with cross-functional teams and across complex ecosystems
Exceptional communication skills, including presenting to senior executives
Experience with Quality Systems including Document Management, Change Control, Deviation and CAPA Management at process, platform, and execution levels
Strong negotiation and interpersonal skills
Excellent stakeholder management and networking skills
Experience leading and implementing change strategies
Experience leading complex projects
Financial acumen
Excellent written and verbal communication skills in English
Ability to translate complex concepts for varied stakeholders
Strong planning and organizational skills
Ability to work independently and in a team
Proven experience in a global matrix environment
People management experience
Ability to translate vision and strategy into executable outcomes
Previous experience with budget, resource management and capacity planning preferred
Good understanding of GxP and Computerized System Validation requirements
Experience in a manufacturing environment
Experience leading diverse, multidisciplinary teams preferred
Operational experience
Process excellence certification such as Six Sigma, LEAN, or DEX green/black belt preferred
Strong sector and global mindset
Strong business acumen
Willingness to travel 20%

Benefits

Comp & perks

Annual bonus with set target depending on pay grade/location, based on employee and company performance
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
Service anniversary and recognition awards
Several insurance plans for employees and, in some locations, eligible dependents