Senior QA Engineer, Digital GxP Systems & AI Validation

Planet Pharma; Bridgewater Township (NJ); On-site; USD 83,000 - 124,000; Full time

Job summary

Planet Pharma is seeking a Senior Associate, Digital Systems Quality Assurance (Contractor) to provide GxP quality oversight and hands-on validation support for a global portfolio of computerized systems and digital platforms.

The role partners with IT, Digital Quality, and cross-functional teams to ensure systems are validated, compliant, and operational per 21 CFR Part 11, EU Annex 11, and EMA Draft Annex 22.

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related field required.
• Minimum 7 years of GxP computerized system validation experience in FDA-regulated industry.
• Knowledge of 21 CFR Part 11 and Eudralex Annex 11 with electronic records/audit trails.

Responsibilities

• Lead or support end-to-end GxP computerized system validation with plan & RTM, aligned with CSA & ISPE GAMP 5.
• Apply risk-based validation approaches considering system complexity and patient safety impact.
• Maintain validation lifecycle docs for enterprise, clinical and lab systems.
• Evaluate changes for revalidation scope and author periodic reviews.
• Develop and review SOPs, WIs, and validation deliverables meeting ALCOA+ data integrity.

Skills

GxP validation

21 CFR Part 11

ISPE GAMP 5

AI/ML validation

Veeva Vault

ServiceNow

Qlik

Entra ID

Education

BSc in Life Sciences

Advanced degree preferred

Tools

Veeva Vault (QMS/RIM/MedComms)

ServiceNow (GxP modules)

Qlik

Entra ID

Job description

Planet Pharma is seeking a Senior Associate, Digital Systems Quality Assurance (Contractor) to provide GxP quality oversight and hands-on validation support for a global portfolio of computerized systems and digital platforms.

The role partners with IT, Digital Quality, and cross-functional teams to ensure systems are validated, compliant, and operational per 21 CFR Part 11, EU Annex 11, and EMA Draft Annex 22.