Senior QA Manager, Commercial Operations (Small-Molecule)

JMD Technologies Inc.; Boston (MA); On-site; USD 103,000 - 117,000; Part time

Job summary

JMD Technologies Inc. seeks a Quality Manager to support commercial operations and finished product quality in a GMP-regulated life sciences environment.

This contract role focuses on product disposition, batch release, investigations, change controls, and ongoing quality compliance with external manufacturing partners. The ideal candidate has a Bachelor's in a scientific field and 5+ years in QA/QM, with strong experience in small-molecule products, batch release, CAPA, deviations, and

Qualifications

• Bachelor’s degree in a scientific or allied health field is preferred.
• 5+ years of relevant Quality Assurance/Quality Management experience.
• Strong knowledge of GMP/GDP and GxP requirements.

Responsibilities

• Manage quality activities supporting commercial finished products, with a focus on small-molecule products.
• Review batch records and coordinate with external manufacturing partners to resolve quality comments.
• Evaluate change controls, investigations, OOS/OOT events, and lot genealogy to support disposition.
• Perform batch release activities and provide GMP release and disposition strategies.
• Provide guidance for root-cause analysis, product impact assessments, and CAPA activities.
• Lead Quality-to-Quality meetings with external manufacturing partners.
• Assess and approve commercial change controls as required.
• Support Quality Agreements, quality metrics, and external partner performance reporting.
• Assist with audit and inspection preparation and post-inspection activities.
• Lead cross-functional quality projects with business and technical stakeholders.
• Apply GMP/GDP regulations, GxP principles, and risk-based quality management.
• Work independently in a high-throughput commercial quality environment.

Skills

Quality Assurance

Quality Management

GMP/GDP knowledge

Batch release

External CMOs coordination

CAPA & investigations

Change controls

Cross-functional leadership

Risk-based quality management

Quality audits

Education

Bachelor’s degree in a scientific or allied health field

Job description

JMD Technologies Inc. seeks a Quality Manager to support commercial operations and finished product quality in a GMP-regulated life sciences environment.

This contract role focuses on product disposition, batch release, investigations, change controls, and ongoing quality compliance with external manufacturing partners. The ideal candidate has a Bachelor's in a scientific field and 5+ years in QA/QM, with strong experience in small-molecule products, batch release, CAPA, deviations, and