Associate Manager, Quality Assurance Operations

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

Role:

Associate Manager, Quality Assurance Operations, overseeing external manufacturing quality compliance for cell/gene therapy biopharma products.

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

Requirements:

• 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

Key biopharma specifics:

focus on cell/gene therapy, cGMP compliance, external manufacturing oversight, validation, and risk management.

Collaboration:

cross-functional engagement with manufacturing, MS&T, QC, and external partners.

Work setup:

• hybrid (3 days/week in Somerville, MA)
• on-call support
• occasional travel