Senior Quality Specialist (Quality Systems)

TL;DR

Senior Quality Specialist (Quality Systems): Supporting global document control and records management programs within the QMS to ensure GxP compliance with an accent on document lifecycle management and regulatory standards. Focus on generating quality metrics, managing change control processes, and collaborating cross-functionally to maintain consistent quality standards.

Location: Must be based in or able to commute to Bridgewater, NJ (Hybrid: 1-2 days/week in-office)

Salary: $100,000–$126,500 Annual

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Manage the Document Change Control process, including lifecycle, classification, and periodic reviews.
• Support the Global Records Management Program and maintain the on-site GxP Archive Room.
• Review and approve SOPs, forms, templates, and technical documents to ensure compliance.
• Track Document Change Controls for timely reviews, approvals, and closure.
• Generate and trend quality metrics for management review and process improvements.
• Train QA and cross-functional stakeholders on QMS processes.

Requirements

• Must be based in or able to commute to Bridgewater, NJ
• BS degree in Chemistry, Life Science, or related discipline.
• 3+ years of relevant Quality Assurance experience in the pharma/biotech industry.
• Direct experience with Document Control management and electronic document management systems (EDMS).
• Full understanding of cGMPs and familiarity with other GxPs (GCP, GVP, GDP, GLP).
• Working knowledge of Change Management Systems and risk-based quality approaches (ICH Q9/Q10).

Nice to have

• Experience with Health Authority inspections and internal audits.
• Understanding of CSV processes, UAT/PQ script execution, and risk assessments.
• Experience with medical device regulations and analytical laboratory practices.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with company match and annual equity awards.
• Generous paid time off and flexible work schedules.
• Access to the Company Learning Institute, LinkedIn Learning, and mentorship programs.
• Supportive environment with employee resource groups and wellbeing reimbursement.