Quality Transformation Lead - Process & Qualification

6084-Janssen Research & Development, LLC Legal Entity; Horsham (PA); On-site; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson's R&D Quality Team seeks a Manager in Process & Personnel Qualification Management to drive compliance and quality excellence in the pharmaceutical industry. You will lead process improvement projects and support the transformation toward a data-centric content and qualification management system.

You will collaborate with Global Development, manage timelines and deliverables, address issues and risks, and communicate progress to stakeholders.

Qualifications

• Education: Bachelor’s degree in Science or Business is required, Masters preferred.
• Experience: 5+ years in a large matrix organization with pharmaceutical/device compliance.
• Communication Skills: Excellent English communication, both oral and written.
• Regulatory Knowledge: Familiar with global (pre)clinical safety and pharmacovigilance regulations.
• Project Management: Ability to manage complex projects and cross-functional teams.
• Analytical Skills: Strong attention to detail and data-driven thinking.
• Leadership and Networking: Proven leadership, collaboration, and inclusive work style.

Responsibilities

• Lead process and training projects including development, mapping, and delivery of training/qualification.
• Serve as a quality partner for Global Development, coordinating with business partners, quality groups, and governance.
• Ensure GxP Quality Framework adapts to regulatory and business changes.
• Manage tasks, timelines, and deliverables to achieve project outcomes.
• Address issues, manage risks, and provide updates to management and owners.
• Support the digital transformation roadmap toward data-centric content and qualification management.
• May support or lead additional projects, audits/inspections as directed.

Job description

Johnson & Johnson's R&D Quality Team seeks a Manager in Process & Personnel Qualification Management to drive compliance and quality excellence in the pharmaceutical industry. You will lead process improvement projects and support the transformation toward a data-centric content and qualification management system.

You will collaborate with Global Development, manage timelines and deliverables, address issues and risks, and communicate progress to stakeholders.