Director, Global CAPA Management

Johnson & Johnson seeks a Director to lead global NC/CAPA quality systems for Innovative Medicine, overseeing process governance, team leadership, and compliance in Schaffhausen.

The company is looking for a Director to act as the Process Lead for Nonconformance and Corrective and Preventive Actions (NC/CAPA) within its Innovative Medicine division. This position provides enterprise-wide leadership to the Global Process Owner, ensuring that standardized processes and governance mechanisms effectively identify, mitigate, and prevent quality issues across the organization. The role also involves overseeing a global team of quality professionals to maintain system health and compliance.

Responsibilities

• Assist the Global Process Owner in operating, maintaining, and improving the NC/CAPA quality system framework.
• Manage global procedural documents, tools, and resources to support the quality process.
• Lead continuous improvement and remediation efforts to keep NC/CAPA processes aligned with business needs and evolving regulatory standards.
• Drive strategic initiatives and projects that represent the requirements for the NC/CAPA process.
• Support process users with training, information, tools, and improvements to optimize execution.
• Establish governance mechanisms, such as the CAPA Review Board, to ensure consistency, transparency, and compliance.
• Lead independent monitoring of the IM NC/CAPA process to identify organizational trends and risks.
• Monitor regulatory expectations and define business requirements for systems, tools, and reporting capabilities.
• Partner with senior stakeholders across Regulatory Compliance, R&D Quality, Supply Chain, and Commercial Quality to ensure appropriate oversight and awareness.
• Support internal and external audit and inspection responses related to the NC/CAPA process.
• Provide strategic leadership and coaching to direct reports to strengthen capability and promote leading practices.

Requirements

• A Bachelor’s degree is required.
• At least 15 years of experience in the pharmaceutical or medical device regulated industry.
• Minimum of 8 years of people management experience.
• Ability to work effectively in a highly matrixed, global organization to drive alignment.
• Expert-level understanding of industry expectations for nonconformance, root cause analysis, and the end-to-end CAPA process.
• Exceptional verbal and written communication skills.
• Experience leading complex projects and initiatives.
• Strong project management skills, including leading teams and initiatives.

Nice to have

• Process Excellence and Project Management training or certification.

What the company offers

• An inclusive work environment where each individual is valued.
• A culture that respects the diversity and dignity of employees and recognizes their merit.

About the company

Johnson & Johnson operates under the guidance of its Credo, with a responsibility to its global workforce. The company’s Innovative Medicine expertise is inspired by patient insights, which fuel science-based advancements in healthcare.

• Guided by the company Credo.
• Responsible to employees working worldwide.
• Patient-inspired expertise in Innovative Medicine.
• Science-based advancements driven by patient insights.