Senior Standards Analyst - Quality & Regulatory

Johnson Johnson; New Brunswick (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Analyst, Standards Specialist to support enterprise quality standards within Enterprise Regulatory Compliance. The role coordinates revisions, partners with SMEs, and ensures updates align with schedules and governance.

Responsibilities include managing change requests, maintaining metrics, and enabling access to standards via internal tools, with focus on AI-enabled workflow improvements while adhering to GxP requirements.

Qualifications

• Bachelor's degree in life sciences, quality, regulatory affairs, engineering, or related field.
• At least five years of quality experience in a regulated industry; pharma or medical device experience preferred.
• Experience with controlled-document authoring, revision, and approval workflows in a regulated environment.

Responsibilities

• Coordinate end-to-end revisions of enterprise quality standards, including change requests and governance packages.
• Partner with SMEs and standards owners to facilitate content and revision updates.
• Route documents through the document management system for review and approval per procedures.
• Maintain the periodic review calendar and support scheduled reviews.
• Track program metrics (revisions, cycle time, backlog, on-time completion) and identify improvements.
• Update internal regulatory standards tools and ensure traceability of references.

Skills

Facilitation

Stakeholder coordination

Attention to detail

Data analysis

Excel proficiency

Education

Bachelor's degree in life sciences or related field

Tools

Excel

Data visualization tools

Document management systems

Job description

Johnson & Johnson is seeking a Senior Analyst, Standards Specialist to support enterprise quality standards within Enterprise Regulatory Compliance. The role coordinates revisions, partners with SMEs, and ensures updates align with schedules and governance.

Responsibilities include managing change requests, maintaining metrics, and enabling access to standards via internal tools, with focus on AI-enabled workflow improvements while adhering to GxP requirements.