Senior QA Operations Manager – Finished Goods Packaging

Insight Global; Boston (MA); On-site; USD 140,000 - 180,000; Full time

Job summary

Insight Global is seeking a QA Manager, Finished Goods Commercial to support a leading life sciences client. The role focuses on QA operations for small molecule finished goods packaging within a CMO network, serving as a primary QA representative and reviewer for batch data and investigations.

The ideal candidate will independently manage batch review, deviations, and packaging-related investigations in a GMP setting, driving release decisions and quality continuity across markets.

Qualifications

• QA operations background (NOT QC).
• Small molecule experience required.
• Finished goods/commercial packaging experience preferred (recent).
• eQMS experience (Veeva Vault strongly preferred; TrackWise acceptable).
• Experience supporting or managing CMOs in a virtual environment.
• Ability to operate independently at a manager level.
• Strong decision-making and risk-based assessment skills in GMP environment.

Responsibilities

• Review executed batch records (EBRs) for commercial packaging operations.
• Support batch disposition activities and batch release decisions.
• Evaluate deviations, investigations, OOS/OOT, and change controls.
• Perform root cause analysis and ensure appropriate CAPAs.
• Act as QA escalation point for packaging and CMO-related quality issues.
• Generate and analyze metrics; track CMO performance.
• Support data handling and reporting for QA operations.
• Lead/participate in Quality-to-Quality meetings with CMOs.
• Provide QA oversight for change controls (assessment, approval, classification).
• Support audit and inspection readiness activities.
• Maintain and support Quality Agreements with external partners.

Skills

QA operations

Small molecules

Finished goods packaging

eQMS experience

CMO management (virtual)

Autonomy as a manager

Risk-based decision making

Job description

Insight Global is seeking a QA Manager, Finished Goods Commercial to support a leading life sciences client. The role focuses on QA operations for small molecule finished goods packaging within a CMO network, serving as a primary QA representative and reviewer for batch data and investigations.

The ideal candidate will independently manage batch review, deviations, and packaging-related investigations in a GMP setting, driving release decisions and quality continuity across markets.