Quality Assurance Manager

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 for a leading life sciences client. This individual will provide critical QA operations support focused on small molecule finished goods packaging within a CMO network. Acting as a key quality representative, this person will independently manage batch record review, deviations, and packaging-related investigations while ensuring compliance with GMP standards. The ideal candidate will bring strong experience in QA operations, the ability to assess risk and make informed quality decisions, and confidence operating in a fast-paced, high-throughput environment. This role will also serve as a primary point of contact for CMO partners, driving quality performance, supporting release activities, and ensuring continuity of product supply across markets.

Must-Haves:

• QA Operations background (NOT QC)
• Small molecule experience
• Finished goods / commercial packaging experience (recent preferred)
• 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

Day-to-Day:

• 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

Plusses:

• Direct Veeva Vault experience (ready to use Day 1)
• Compliance background in packaging/labeling/finished goods
• Biologics experience paired with understanding of small molecule operations
• Experience with bulk manufacturing + exposure to finished goods processes
• Strong project management and continuous improvement experience
• Prior experience leading cross-functional teams and influencing stakeholders
• Root cause analysis expertise (deviations, OOS, OOT)