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 subject matter experts 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, including revisions, cycle time, on-time completion, and backlog
Identify trends and opportunities to improve standards-program efficiency and predictability
Facilitate updates to internal regulatory standards tools and maintain traceability of regulations, guidance, references, and sections
Partner with Regulatory Intelligence managers on periodic environmental scans
Coordinate updates to the internal standards website so stakeholders can locate current standards and supporting resources
Build AI literacy and apply approved AI tools to streamline workflows while following governance, privacy, and compliance requirements
Shape and drive continuous improvement projects for the enterprise quality standards program

What you’ll need

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
Working knowledge of quality system documentation concepts, including standards, policies, and SOPs
Working knowledge of GxP and 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
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 with direction, manage deadlines, and collaborate effectively with cross-functional partners
Pharmaceutical or medical device experience preferred
Experience supporting controlled-document authoring, revision, and approval workflows in a regulated environment preferred

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Eligibility for the Company’s long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive work environment
Access to company benefits information and employee benefits programs