Senior GxP Digital Systems QA Engineer

Planet Pharma; Bridgewater (MA); On-site; USD 73,012 - 86,788; Full time

Job summary

Planet Pharma is seeking a QA professional to provide quality oversight of GxP computerized systems across their lifecycle, ensuring compliance with FDA, EMA, and ICH requirements to protect patient safety and product quality. You will partner with IT, CSV, and vendor teams, review validation deliverables, assist during inspections, and apply risk-based validation strategies per CSA and ISPE GAMP 5.

Located in Massachusetts, this role emphasizes electronic records controls, audit trails, and

Qualifications

• Minimum 7 years QA/validation in FDA-regulated pharma/biotech.
• Experience supporting GxP lifecycle for computerized systems.
• Proficient with Change Control, Deviation, CAPA and supplier quality.
• Familiar with 21 CFR Part 11 and Eudralex Annex 11.
• Experience with SaaS/cloud systems and vendor audits.

Responsibilities

• Provide QA oversight across full lifecycle of GxP systems.
• Review and approve CSV deliverables (URS, FS, validation docs).
• Ensure compliance with 21 CFR Part 11 and annex 11.
• Lead risk-based validation strategy per FDA CSA and ISPE GAMP 5.
• Support inspections and audit readiness activities.

Skills

GxP systems

CSV/ISPE GAMP 5

21 CFR Part 11

CSA guidance

Veeva Vault QMS

ServiceNow

Qlik

ALCOA+

Audit readiness

Quality risk management

Education

Bachelor’s degree in Life Sciences/CS/Engineering

7+ years QA/Validation experience

Tools

Veeva Vault

ServiceNow

Qlik

Entra ID

LIMS/ELN validation

Job description

Planet Pharma is seeking a QA professional to provide quality oversight of GxP computerized systems across their lifecycle, ensuring compliance with FDA, EMA, and ICH requirements to protect patient safety and product quality. You will partner with IT, CSV, and vendor teams, review validation deliverables, assist during inspections, and apply risk-based validation strategies per CSA and ISPE GAMP 5.

Located in Massachusetts, this role emphasizes electronic records controls, audit trails, and