Director of Digital Systems Quality Assurance (DSQA)

TL;DR

Director of Digital Systems Quality Assurance (DSQA): Establishing, leading, and improving quality oversight of GxP digital systems for clinical development, data management, and biometrics with an accent on data integrity controls, regulatory compliance, and lifecycle management. Focus on computer software validation, IT change control facilitation, and QA review of CSV documents.

Location: Hybrid role based out of Bridgewater, NJ Headquarters. Travel Requirements: approximately 30% domestic/international.

Salary: $177,000–$242,000 Annual

Company

Global biopharmaceutical company dedicated to transforming lives of patients with serious and rare diseases.

What you will do

• Partner with business to evaluate needs and ensure solutions align with data integrity and compliance requirements.
• Provide oversight for implementation, validation, and maintenance of GxP software applications, interfaces, upgrades, and change controls.
• Guide teams on software development lifecycle, computer validation, and risk-based approaches.
• Work with project teams to meet regulatory requirements from FDA, EMA, PMDA, and others.
• Write SOPs, support regulatory inspections, internal audits, and QA review of GMP records like deviations and CAPAs.
• Lead department through objective setting, performance appraisal, and development for multiple projects.

Requirements

• Bachelor’s degree and minimum 10 years relevant Quality Assurance experience (or MS + 5 years).
• Experience implementing, validating, maintaining, and integrating electronic document and Quality Management systems in FDA-regulated settings.
• QA reviewer experience for GMP records: CSV protocols, deviations, CAPA, SOPs.
• Experience with Veeva Clinical systems, IRT/eCOA, Data Management software required.
• Excellent communication skills; ability to manage projects and variable workloads.
• Highly organized with strong attention to detail, accuracy, and conciseness.

Nice to have

• Experience in Data Integrity, 21 CFR Part 11, Annex 11, GAMP 5, SDLC (Agile or Waterfall), CSA.

Culture & Benefits

• Comprehensive medical, dental, vision coverage, mental health support, wellbeing reimbursement, EAP.
• Generous PTO, fertility/family benefits, caregiver support, flexible schedules.
• 401(k) with company match, equity awards, ESPP, company-paid life/disability insurance.
• Learning Institute with LinkedIn Learning, workshops, leadership programs, mentorship.
• Employee resource groups, recognition programs, volunteering opportunities.