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 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 foster a high-performance culture while ensuring adherence to GxP standards.

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 StrategyChange ControlDeviation ManagementQuality MetricsKPI ImplementationBudget ManagementResource ManagementCapacity PlanningGxP Documentation

Soft Skills

Exceptional Communication SkillsNegotiation SkillsInterpersonal SkillsPlanning SkillsOrganizational Skills

Tools & Technologies

Trending ToolsDocument Management SystemsQuality SystemsInspection Readiness ToolsGovernance Forums

Certifications & Qualifications

Six Sigma CertificationLEAN CertificationDEX Green/Black Belt

Industry Keywords

Global Matrix EnvironmentManufacturing EnvironmentQuality & ComplianceCross-Functional CollaborationProcess Improvement

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
Lead investigation improvement initiatives across the network with key partners
Own the quality escalation/notification system and technical solutions such as trending tools
Champion quality, accountability, and quality culture with business partners and stakeholders
Plan functional objectives, resources, and long-term capabilities
Oversee the IM NC/CAPA quality system and Issue Escalation processes
Lead independent monitoring of IM NC/CAPA processes to support inspection readiness and CAPA oversight
Establish global governance programs for IM NC/CAPA processes and metrics
Provide escalation metrics and trending data to Quality & Compliance organizations
Interact with senior leaders regarding compliance status and key risks
Lead governance forums for NC/CAPA and maintain escalation and review processes
Develop strategic imperatives and functional capabilities
Maintain GxP documentation according to Johnson & Johnson standards and local regulatory requirements
Review and report on quality management system performance
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
Participate in industry forums and initiatives to benchmark best practices and influence standards
Ensure implementation and remediation activities comply with new or revised quality requirements
Represent the organization in governance forums and audits
Lead quality issue and nonconformance management, escalation, and resolution
Implement and monitor quality metrics and KPIs
Collaborate with R&D, Regulatory Affairs, and Operations to integrate quality processes
Build and lead a diverse global quality team and foster a high-performance culture

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 their management systems journey
Track record of collaboration 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 level
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 budget, resource management, and capacity planning experience preferred
Understanding of GxP and Computerized System Validation requirements preferred
Manufacturing environment experience preferred
Experience leading diverse, multidisciplinary teams preferred
Operational experience preferred
Process excellence certification, such as Six Sigma, LEAN, or DEX green/black belt, preferred
Strong sector and global mindset preferred
Strong business acumen preferred

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
Insurance plans for employees and, in some locations, eligible dependents