Senior Analyst, Standards Specialist

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Documentation

Job Category:

Professional

All Job Posting Locations:

Georgia (Any City), Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Toronto, Ontario, Canada

Job Description:

Johnson & Johnson is currently seeking a Senior Analyst, Standards Specialist, to join our Enterprise Regulatory Intelligence function within J&J's Enterprise Regulatory Compliance organization.

Introduction to the Role

The Standards Specialist, Senior Analyst, supports the enterprise quality standards program by coordinating and facilitating timely updates to enterprise quality standards and related tools. This role manages the day-to-day execution of the standards revision process by partnering with sector subject matter experts (SMEs) to incorporate approved changes, routing documents through the document management system for review and approval, and ensuring that updates are implemented according to the agreed-upon schedule. The Senior Analyst also maintains program metrics and supports ongoing access to standards content through internal systems and the standards website.

Responsibilities/Principal Duties

• Coordinate end-to-end revisions of enterprise quality standards, including intake and tracking of change requests, review of change assessments for completeness and clarity, 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, ensuring that documents are published in accordance with applicable procedures.
• Maintain the periodic review calendar and support scheduled reviews to ensure standards are reviewed and updated according to the defined program commitments.
• Maintain and report program metrics (e.g., number of revisions, cycle time, on-time completion, backlog), identifying trends and opportunities to improve the efficiency and predictability of the standards program.
• Facilitate updates to internal regulatory standards tools by documenting the regulations or guidance that drove specific standard updates and ensuring that related references and sections are updated and traceable.
• Partner with Regulatory Intelligence managers to conduct periodic environmental scans that inform the continuous improvement of enterprise standards.
• Ensure access to standards by coordinating updates to the internal standards website so that stakeholders can easily locate current standards and supporting resources.
• Actively build AI literacy and fluency and apply approved AI tools to streamline standards program workflows (e.g., change-request triage, drafting and editing support, and publishing coordination) while adhering to appropriate governance, privacy, and compliance requirements.
• Help to shape, and drive execution of continuous improvement projects that enhance effectiveness, value and efficiency of the enterprise quality standards program.

Qualifications

A bachelor's degree in life sciences, quality, regulatory affairs, engineering, or a related field is required.

Required Related Experience: At least five years of quality experience in a regulated industry; pharmaceutical or medical device experience is preferred. Experience supporting controlled-document authoring, revision, and approval workflows in a regulated environment is preferred.Working knowledge of quality system documentation concepts (e.g., standards, policies, SOPs) and fundamentals of GxP/medical device requirements.Strong facilitation and stakeholder coordination skills, with the ability to drive timelines, manage review cycles, and resolve issues in a matrixed environment.Excellent attention to detail and ability to ensure document consistency and traceability.Experience maintaining program metrics and dashboards.Proficiency in Excel and in analyzing trends such as cycle time, backlog, and on-time completion.Proficiency in data visualization applications and a working knowledge of process automation techniques.Pro