Senior Analyst, Standards Specialist

. Coordinate end-to-end revisions of enterprise quality standards .

Posted 9/25/2026full-timeNew Brunswick • United StatesSenior💰 $94,000 - $151,800 per yearWebsite

Key responsibilities & impact

Coordinate end-to-end revisions of enterprise quality standards
Intake and track change requests
Review change assessments for completeness and clarity
Prepare 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
Ensure documents are published according to applicable procedures
Maintain the periodic review calendar and support scheduled reviews
Maintain and report program metrics, identifying trends and improvement opportunities
Facilitate updates to internal regulatory standards tools and ensure references and sections are traceable
Partner with Regulatory Intelligence managers on periodic environmental scans
Coordinate updates to the internal standards website
Apply approved AI tools to streamline standards workflows while adhering to governance, privacy, and compliance requirements
Drive continuous improvement projects for the enterprise quality standards program

What you’ll need

A 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
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, including standards, policies, and SOPs
Working knowledge of GxP/medical device requirements
Strong facilitation and stakeholder coordination skills
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 analyzing trends such as cycle time, backlog, and on-time completion
Proficiency in data visualization applications and working knowledge of process automation techniques
Proficiency with document management systems such as Veeva and collaboration tools such as SharePoint
Strong written communication skills, including editing controlled content and coordinating updates with technical SMEs
Commitment to data integrity and accuracy
Ability to work independently, manage deadlines, and collaborate effectively with cross-functional partners

Comp & perks

Pension plan
401(k) savings plan
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; Colorado residents – 48 hours; Washington residents – 56 hours
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 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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year