Senior Standards & Quality Analyst

Johnson Johnson; Horsham (PA); On-site; USD 94,000 - 152,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Sick time 40 hours/year

13 floating holidays

Job summary

Johnson & Johnson is seeking a Senior Analyst, Standards Specialist, to join the Enterprise Regulatory Intelligence function within Enterprise Regulatory Compliance. The role coordinates and facilitates timely updates to enterprise quality standards, partnering with sector SMEs to incorporate approved changes and route documents through the system for review and approval.

The Senior Analyst maintains program metrics, supports access to standards content, and helps drive continuous improvement of

Qualifications

• Bachelor's degree in life sciences, quality, regulatory affairs, engineering, or a related field is required.
• At least five years of quality experience in a regulated industry; pharma or medical device experience preferred.
• Experience supporting controlled-document authoring, revision, and approval workflows in a regulated environment is preferred.
• Strong facilitation and stakeholder coordination skills with the ability to drive timelines and manage review cycles.
• Proficiency in Excel and in analyzing trends; experience with data visualization and process automation.
• Experience with document management systems (e.g., Veeva) and collaboration tools (e.g., SharePoint).
• Excellent written communication skills with an ability to edit controlled content and coordinate updates with SMEs.

Responsibilities

• Coordinate end-to-end revisions of enterprise quality standards and track change requests.
• Partner with sector SMEs and standards owners to update content.
• Route standards through the document management system for review and approval.
• Maintain the periodic review calendar and support scheduled reviews.
• Report program metrics (e.g., revisions, cycle time, on-time completion).
• Update internal regulatory standards tools and ensure traceability of references.
• Collaborate with Regulatory Intelligence managers on environmental scans for continuous improvement.
• Ensure access to standards via internal website and resources.
• Build AI literacy and apply approved AI tools to streamline workflows while complying with governance.

Skills

Quality experience

Stakeholder coordination

Data analysis

Excel

Process improvement

Technical writing

Education

Bachelor's degree in life sciences/quality/regulatory/engineering

Tools

Veeva

SharePoint

Job description

Johnson & Johnson is seeking a Senior Analyst, Standards Specialist, to join the Enterprise Regulatory Intelligence function within Enterprise Regulatory Compliance. The role coordinates and facilitates timely updates to enterprise quality standards, partnering with sector SMEs to incorporate approved changes and route documents through the system for review and approval.

The Senior Analyst maintains program metrics, supports access to standards content, and helps drive continuous improvement of