Quality Assurance Consultant

Contract Duration

3-4 months

Rate

$65-80/hour. (Negotiable/commensurate w/ experience)

Position Summary

The Senior GMP Quality Assurance Consultant will provide hands-on QA support for clinical and commercial gene therapy manufacturing. Reporting to the Director of GMP Quality Assurance, this consultant will provide real-time quality oversight, review and approve GMP documentation, support product disposition, and resolve complex quality issues in partnership with Manufacturing, QC, Regulatory, and Technical Operations.

Key Responsibilities

• Provide on-the-floor GMP Quality Assurance oversight for gene therapy manufacturing operations.
• Review and approve executed and master batch records, deviations, investigations, CAPAs, change controls, and other GMP manufacturing documentation.
• Support drug substance (DS) and drug product (DP) disposition activities.
• Evaluate complex quality and compliance issues associated with gene therapy manufacturing and provide risk-based QA guidance.
• Review manufacturing records, raw laboratory data, analytical results, and method validation documentation for GMP compliance.
• Provide real-time QA guidance during manufacturing and elevate potential product-quality or compliance risks.
• Partner with Manufacturing, QC, Regulatory, and Technical Operations to resolve quality issues and maintain inspection readiness.
• Support regulatory inspections and ensure documentation is complete, scientifically justified, and audit-ready.

Required Qualifications

• Bachelor's degree in Biology, Chemistry, Biotechnology, Engineering, or related scientific/technical discipline.
• 8+ years of direct GMP Quality Assurance experience within the gene therapy industry.
• Demonstrated QA experience supporting gene therapy product manufacturing, preferably viral vector based products.
• Direct experience providing QA support on the manufacturing floor.
• Experience reviewing and approving executed batch records and complex GMP documentation.
• Experience supporting DS and DP product disposition.
• Experience reviewing raw data, laboratory records, analytical results, and method validation documentation.
• Strong knowledge of FDA regulations, ICH guidelines, cGMP requirements, deviations, CAPAs, change controls, investigations, and risk management.
• Ability to independently assess complex quality issues and make sound, risk-based QA decisions.

Preferred Qualifications

• QA experience supporting both clinical and commercial CGT manufacturing.
• Viral vector and/or advanced gene therapy experience.
• Regulatory inspection and inspection-readiness experience.
• Experience with electronic QMS and electronic batch record systems.
• Previous consulting experience in a GMP gene therapy environment.