Senior Analyst, Quality Standards & Regulatory Docs

Johnson Johnson; Illinois; On-site; USD 94,000 - 152,000; Full time

Benefits offered by this job

Vacation 120 hrs

Sick time 40 hrs

Holidays

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson is seeking a Senior Analyst, Standards Specialist to join our Enterprise Regulatory Compliance team. You will coordinate end-to-end revisions of enterprise quality standards, partner with sector SMEs, route documents for review, and ensure updates align with schedules.

You will also maintain program metrics, support internal standards tools and websites, and apply AI-enabled workflows with appropriate governance to improve efficiency in a regulated environment.

Qualifications

• Bachelor’s degree in life sciences, quality, regulatory affairs, engineering, or related field is required.
• Five years of quality experience in a regulated industry; pharma/medical device preferred.
• Experience supporting controlled-document authoring, revision and approval workflows in a regulated environment.

Responsibilities

• Coordinate end-to-end revisions of enterprise quality standards, including intake and tracking of change requests, and preparation of revision packages for governance review.
• Partner with sector SMEs and standards owners to facilitate content and revision updates.
• Route standards and related documents through the document management system for review and approval.
• Maintain the periodic review calendar and support scheduled reviews to ensure standards are updated.
• Maintain and report program metrics such as revisions, cycle time, and backlog.
• Facilitate updates to internal regulatory standards tools and ensure traceability.
• Collaborate with Regulatory Intelligence managers on environmental scans to improve standards.
• Ensure access to standards via internal website and resources.
• Build AI literacy and apply approved AI tools to streamline workflows with governance.
• Lead continuous improvement projects for the standards program.

Skills

Facilitation

Stakeholder coordination

Attention to detail

Data integrity

Excel

Data visualization

Process automation

Document management systems

Written communication

Education

Bachelor’s degree in life sciences, quality, regulatory affairs, engineering

Tools

Excel

Veeva

SharePoint

Job description

Johnson & Johnson is seeking a Senior Analyst, Standards Specialist to join our Enterprise Regulatory Compliance team. You will coordinate end-to-end revisions of enterprise quality standards, partner with sector SMEs, route documents for review, and ensure updates align with schedules.

You will also maintain program metrics, support internal standards tools and websites, and apply AI-enabled workflows with appropriate governance to improve efficiency in a regulated environment.