QA Validation Specialist - Cell and Gene Therapy

BioPharma Consulting JAD Group; Boston (MA); On-site; USD 83,000 - 138,000; Part time

Job summary

BioPharma Consulting JAD Group in Boston, MA seeks a QA Validation professional to oversee CQV, validation oversight, and continuous improvement of CQV programs in a cGMP cell and gene therapy facility. The role emphasizes IQ/OQ/PQ, CSV, and complex change controls within a fast-paced biotech setting.

The candidate should hold a technical degree with 5+ years of validation/QA experience (or 7+ years equivalent), plus familiarity with 21 CFR, ICH, EU regulations, GAMP 5, and risk-based

Qualifications

• Bachelor’s degree in a technical discipline and 5 years of validation/QA experience (or 7+ years equivalent).
• 21 CFR, ICH, EU regulations, GAMP 5 and risk-based validation.
• Kneat strongly preferred. Cell and gene therapy or contract manufacturing experience preferred.

Responsibilities

• Provide QA oversight of CQV, periodic review and requalification.
• Review and approve validation protocols and reports (IQ, OQ, PQ, CSV, process and cleaning validation).
• Review CMMS records for asset release, database requests and work orders.
• Author and review SOPs in Veeva.
• Support change controls, risk assessments, deviations, audits and inspections.

Skills

QA validation

Regulatory knowledge

GAMP 5

Education

Bachelor’s degree in technical discipline

5+ years validation/QA experience (or 7+ years equivalent)

Tools

Kneat

Job description

Join a growing QA Validation group at a leading biotechnology company in Boston, Massachusetts. You will provide QA oversight of commissioning, qualification and validation for a cGMP cell and gene therapy manufacturing facility and its QC laboratories.

What you'll do

• Provide QA oversight of CQV, periodic review and requalification.
• Review and approve validation protocols and reports (IQ, OQ, PQ, CSV, process and cleaning validation).
• Review CMMS records for asset release, database requests and work orders.
• Author and review SOPs in Veeva.
• Support change controls, risk assessments, deviations, audits and inspections.

• Bachelor's degree in a technical discipline + 5 years of validation and/or QA experience (or 7+ years equivalent).
• 21 CFR, ICH, EU regulations, GAMP 5 and risk-based validation.
• Kneat strongly preferred.
• Cell and gene therapy or contract manufacturing experience preferred.

• Contract: 6–12 months, with possible extension
• Shift: Administrative, Monday–Friday
• Start: Immediate