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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.Proficiency with document management systems (e.g., Veeva) and collaboration tools (e.g., SharePoint).Strong written communication skills, including the ability to edit controlled content and coordinate updates with technical SMEs.Excellent attention to detail and commitment to data integrity and accuracy.Ability to work independently with direction, manage deadlines, and collaborate effectively with cross-functional partners.
Required Skills:
Preferred Skills:
Business Valuations, Coaching, Communication, Compliance Management, ISO 9001, Problem Solving, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Systems Documentation, Regulatory Affairs Management, Regulatory Environment, Relationship Building, Researching, Standard Operating Procedure (SOP), Technical Writing, Time Management
The anticipated base pay range for this position is :
$94,000.00 - $151,800.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
