Director, Global CAPA Management

Johnson & Johnson Innovative Medicine • Horsham, PA

3d • $150,000 - $258,750 • Hybrid

About The Position

The Director, Global CAPA Management serves as the Innovative Medicine (IM) Process Lead for NC/CAPA in support of the Global Process Owner (GPO), providing enterprise-wide leadership for the global NC/CAPA quality system. This role is responsible for maintaining, improving, and implementing standardized processes, governance, metrics, and oversight mechanisms that enable effective identification, mitigation, and prevention of quality and compliance issues across IM. The Director works with the GPO to translate strategy into action plans and partners closely with senior leaders and cross-functional stakeholders to strengthen inspection readiness, quality culture, operational excellence, and sustained compliance.
This leader oversees a global team of quality professionals and drives continuous improvement of NC/CAPA procedures, tools, and system capabilities, including the translation of evolving business and regulatory requirements into clear process and user requirements for digital platforms. The Director ensures robust process health assessment, issue trending, risk identification, and governance review, while enabling alignment across regions and functions. Through strategic leadership, stakeholder engagement, and change management, this role advances a consistent, data-driven, and effective NC/CAPA framework that supports the IM quality management system.

Requirements

• A minimum of a Bachelor’s degree is required.
• At least 15 years of related experience in the pharmaceutical/medical device regulated industry is required, and a minimum of 8 years of people management experience required.
• Must be able to effectively work in a highly matrixed organization, working across a global organization to drive alignment
• High degree of interdependent partnering, influencing, and team work required.
• Expert level of understanding of industry expectations for nonconformance, root cause analysis, corrective and preventive actions (end-to-end CAPA process) required.
• Consistent track record of collaboration, including the ability to work with global, cross-functional teams, and across complex matrixed organizations.
• Strong negotiation and interpersonal skills to achieve and maintain alignment with stakeholder partners, required.
• Exceptional communications skills required verbally and in writing (including ability to translate complex concepts into clear communications, ability to create executive messaging necessary for presenting to senior executives, and ability to effectively listen and respond to inputs from broad base of stakeholders at all organizational levels).
• Experience leading complex projects required.
• Operates in a highly self-directed manner with minimal guidance to deliver strategic objectives.
• Uses appropriate project management tools to manage and track activities.
• Ability to manage multiple projects and priorities to remain effective and focused on business critical objectives required.
• Project Management experience, leading initiatives and teams, is required.

Nice To Haves

• Process Excellence and Project Management training/certification preferred.

Responsibilities

• Support the Global Process Owner in operating, maintaining, improving, and remediating the NC/CAPA quality system framework.
• Manage and maintain global procedural documents, tools, and resources in support of the process.
• Drive continuous improvement and remediation activities to ensure NC/CAPA processes remain aligned with business needs and evolving quality/compliance requirements.
• Lead projects or support strategic initiatives representing the requirements for the NC/CAPA process.
• Drive implementation of one quality system.
• Support process Users with adequate training, information, tools and process improvements to enable optimized execution.
• Establish and manage governance mechanisms, including CAPA Review Board processes, to ensure the health of the quality system NC/CAPA process enabling consistency and transparency into overall process effectiveness and compliance.
• Lead independent monitoring of IM NC/CAPA process to identify trends and risks at an IM organizational level.
• Monitor regulatory expectations and define business/user requirements for systems, tools, and reporting capabilities used to execute and oversee NC/CAPA processes.
• Partner with IM functions and senior stakeholders across Regulatory Compliance, R&D Quality, Supply Chain, External Supplier Quality, and Commercial Quality to ensure appropriate oversight, engagement, and awareness of compliance health.
• Support external and internal audit and inspection responses related to the NC/CAPA process in partnership with the Global Process Owner.
• Provide strategic leadership and coaching to direct reports to strengthen capability, ensure alignment with standards, and promote leading NC/CAPA practices.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Director