Senior GxP Validation QA Specialist (Enterprise Systems)

cyberThink Inc; Bridgewater Township (NJ); Vor Ort; USD 76.000 - 90.000; Vollzeit

Zusammenfassung

cyberThink Inc. in New Jersey seeks a seasoned QA professional to provide quality oversight of GxP computerized systems across their lifecycle, ensuring compliance with FDA/EMA/ICH requirements in support of patient safety and product quality.

The role partners with IT, CSV and vendor teams, applying risk-based validation strategies, reviewing URS, FS, validation plans, protocols, test scripts, and reports, and supporting regulatory inspections.

Qualifikationen

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field preferred.
• Minimum 7 years of experience in Quality Assurance and/or Validation within FDA-regulated pharma/biotech.
• Demonstrated experience supporting regulatory inspections and audit readiness.
• Experience with Change Control, Deviation, CAPA, and Supplier Quality.
• In-depth knowledge of 21 CFR Part 11 and Eudralex Volume 4 Annex 11.

Aufgaben

• Provide QA review and approval of CSV deliverables (URS, FS, validation plans, protocols, test scripts, reports).
• Maintain QA oversight of GxP computerized systems throughout their lifecycle.
• Collaborate with IT, CSV, vendors to apply risk-based validation approaches and ensure validated state.

Kenntnisse

Quality Assurance

Validation

Regulatory inspections

GxP systems

CSA guidance

Data integrity

ALCOA+

Ausbildung

Bachelor's degree

Tools

Veeva Vault (QMS, RIM, MedComms, MedInquiry)

ServiceNow

Qlik

Entra ID

Jobbeschreibung

cyberThink Inc. in New Jersey seeks a seasoned QA professional to provide quality oversight of GxP computerized systems across their lifecycle, ensuring compliance with FDA/EMA/ICH requirements in support of patient safety and product quality.

The role partners with IT, CSV and vendor teams, applying risk-based validation strategies, reviewing URS, FS, validation plans, protocols, test scripts, and reports, and supporting regulatory inspections.