Senior QA Specialist - Gene Therapy GMP & Compliance Lead

Genezen Inc.; Lexington (MA); Hybride; USD 100 000 - 115 000; Plein temps

Avantages offerts par ce poste

Paid vacation days

401(k) with company match

Healthcare plans

FSA/HSA programs

Life insurance

Disability insurance

Résumé du poste

Genezen Inc. is seeking a Senior QA Analyst to champion regulatory compliance on the manufacturing floor in Lexington, MA.

You will lead the Quality Management System, manage deviations and CAPAs, and review critical manufacturing documents to ensure product quality and regulatory readiness. You will collaborate with cross-functional teams, perform batch dispositions, and provide QA support for aseptic fill operations while mentoring junior staff.

Qualifications

• 8+ years of GMP experience in pharma/biotech with a regulated GMP environment.
• Experience in cGMP manufacturing and adherence to FDA/ICH/EU guidelines.
• Strong written and verbal communication and cross-functional collaboration.
• Proficient in Microsoft Office applications (Outlook, Word, Excel, PowerPoint).
• Capable of working with minimal supervision in a fast-paced setting.

Responsabilités

• Oversee QA regulatory compliance on the manufacturing floor.
• Administer QMS activities including deviations, CAPAs, change controls.
• Review and approve Manufacturing documents (SOPs, batch records, logs).
• Perform QA walkthroughs to maintain inspection readiness.
• Support batch disposition and aseptic fill operations.

Connaissances

GMP/CGMP compliance

CAPA investigations

Deviation management

QMS ownership

Document review/approval

Regulatory liaison

Training & mentorship

Data integrity

Formation

BS in science or engineering

Outils

MS Office

Description du poste

Genezen Inc. is seeking a Senior QA Analyst to champion regulatory compliance on the manufacturing floor in Lexington, MA.

You will lead the Quality Management System, manage deviations and CAPAs, and review critical manufacturing documents to ensure product quality and regulatory readiness. You will collaborate with cross-functional teams, perform batch dispositions, and provide QA support for aseptic fill operations while mentoring junior staff.