Remote CSV Lead: GxP Systems & Compliance

Astellas Pharma; Westborough (MA); Hybrid; USD 105,280 - 150,400; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

PTO & Holidays

401k match

Life Insurance

Bonus Program

Company vehicle

Referral bonus

Job summary

Astellas Pharma in Westborough, MA seeks a CSV Lead to develop, execute and maintain the validation strategy for GxP computerized systems supporting manufacturing, laboratory and quality operations. This role ensures compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 while aligning with corporate best practices.

The expert will author and review CSV deliverables, collaborate with cross‑functional teams, and drive continuous validation across upgrades and configurations to ensure data

Qualifications

• Bachelor’s degree in science/engineering or related field with 5–8 years in CSV or IT quality.
• Deep knowledge of GxP, GAMP 5, and 21 CFR Part 11/Annex 11 compliance.
• Experience validating enterprise and lab systems (LIMS/MES/QMS/ERP).

Responsibilities

• Lead validation projects for GxP computerized systems (manufacturing, lab, quality).
• Create and review CSV deliverables: plans, URS, FS, DQ, IQ/OQ/PQ, reports.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and SOPs.
• Collaborate with IT, QA, Manufacturing, Lab, and vendors on scope & strategy.
• Lead impact assessments for upgrades, patches, and configurations.
• Support data integrity initiatives and periodic review programs.
• Manage audit readiness and support FDA/EMA inspections.
• Develop and maintain validation templates, SOPs, and training.

Skills

GxP principles

GAMP 5

Technical writing

Project management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in CS/Engineering/Life Sciences

Master’s Degree (MBA/MIS) preferred

Tools

LIMS

MES

QMS

ERP

OSI PI

Empower

SAP

LabWare

Job description

Astellas Pharma in Westborough, MA seeks a CSV Lead to develop, execute and maintain the validation strategy for GxP computerized systems supporting manufacturing, laboratory and quality operations. This role ensures compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 while aligning with corporate best practices.

The expert will author and review CSV deliverables, collaborate with cross‑functional teams, and drive continuous validation across upgrades and configurations to ensure data