Quality Manager, Finished Goods Commercial

JMD Technologies Inc.; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

JMD Technologies Inc. in Boston is seeking a QA Manager to lead finished goods quality activities for Commercial products under a contract.

You will oversee batch release, investigations, CAPA, and audits, and partner with CMOs and external partners to ensure timely product release and regulatory compliance. The ideal candidate holds a BS in a scientific field, 5+ years of QA/GMP experience, strong root-cause analysis, problem solving, and proven leadership of cross-functional teams in a

Qualifications

• Bachelor’s degree in science or allied field.
• 5+ years of QA/GMP experience.
• Knowledge of GMP/GDP and risk management.
• Strong analytical and communication skills.

Responsibilities

• Finished Goods Disposition & Batch Release: review batch records, assess compliance, support release decisions.
• Quality & Investigation Support: root-cause analysis, triage deviations and investigations, identify CAPA actions.
• CMO & External Partner Management: collaborate with CMOs, lead quality meetings, ensure timely product release.
• Audit & Inspection Support: prepare for audits, provide back-room support, assist post-inspection activities.

Skills

Root-cause analysis

Problem solving

Cross-functional leadership

Project management

GxP knowledge

Education

Bachelor’s degree in a scientific field

Job description

Titile: QA Manager, Finished Goods Commercial

Employment Type: Contract

Status: Accepting Candidates

We are seeking a Quality Manager to provide oversight of quality activities supporting Finished Goods Commercial Product. This role will manage multiple department activities, troubleshoot complex quality issues, and work closely with business partners and external partners to support continued supply and compliance with regulatory requirements.

Key Responsibilities

Finished Goods Disposition & Batch Release

• Review Executed Batch Records (EBRs) for commercial packaging operations
• Review change controls against full lot genealogy and determine material compliance
• Evaluate Investigations, OOS, and Change Controls to support disposition decisions
• Perform batch release activities

Quality & Investigation Support

• Provide quality guidance for root-cause analysis and product impact assessments
• Triage deviations, OOS, and OOT investigations and escalates as needed
• Ensure appropriate CAPA actions are identified
• Serve as QA assessor/approver on Commercial Change Controls

CMO & External Partner Management

• Develop relationships with strategic external partners
• Lead Quality-to-Quality meetings with CMO partners
• Influence timely completion of CMO product release and Right First Time activities
• Assist with Quality Agreements and metrics generation

Audit & Inspection Support

• Provide audit and inspection preparation support
• Provide back-room support as needed
• Support post-inspection activities

Qualifications

• Bachelor’s degree in a scientific or allied health field
• 5+ years of relevant experience
• Strong knowledge of global GMP requirements governing oral drug products
• Knowledge of oral drug product manufacturing practices
• Experience with GMP/GDP regulations and manufacturing/testing risk management principles
• Strong root-cause analysis and problem-solving skills

Preferred Qualifications

• Strong leadership skills in a high-throughput environment
• Experience leading cross-functional teams and projects
• Strong project management and continuous improvement skills
• Ability to make risk-based quality decisions independently
• Broad GxP knowledge across the product lifecycle
• Strong communication, collaboration, and influencing skills
• Experience supporting audits and inspections
• Strong attention to detail, flexibility, and sense of urgency