Associate QA Manager: Cell/Gene Therapy & CMO Oversight

Scorpion Therapeutics; Boston (MA); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Manager for Quality Assurance Operations to oversee external manufacturing quality compliance for cell/gene therapy products. You will provide QA support for manufacturing, drive deviation handling and validation, and serve as the QA point for product complaints.

The role involves cross-functional collaboration with manufacturing, MS&T, QC, and external partners, with a hybrid schedule (3 days/week in Somerville, MA) and occasional travel.

Qualifications

• Bachelor’s in Life Sciences or related field.
• 4-6 years QA experience in GMP biopharma or cell/gene therapy manufacturing.
• Strong knowledge of cGMP regulations, deviation management, and validation.
• Experience with CMO oversight.
• Familiarity with lentiviral vectors and biologics preferred.

Responsibilities

• Provide QA support for manufacturing.
• Lead oversight of CMOs.
• Review deviations, change controls, and validation protocols.
• Serve as QA point for product complaints.
• Monitor quality metrics and drive continuous improvement.
• Manage Quality Agreements and author Annual Product Quality Reviews.

Skills

QA compliance

CMO oversight

Deviation management

cGMP knowledge

Validation

Education

Bachelor’s in Life Sciences or related field

Job description

Scorpion Therapeutics is seeking an Associate Manager for Quality Assurance Operations to oversee external manufacturing quality compliance for cell/gene therapy products. You will provide QA support for manufacturing, drive deviation handling and validation, and serve as the QA point for product complaints.

The role involves cross-functional collaboration with manufacturing, MS&T, QC, and external partners, with a hybrid schedule (3 days/week in Somerville, MA) and occasional travel.