Quality Manager – Commercial Operations

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

Title: Quality Manager – Commercial Operations

Employment Type: Contract

Duration: 12+ Months

Status: Accepting Candidates

About the Role

We are seeking an experienced Quality Manager to support commercial operations and finished product quality activities within a GMP-regulated life sciences environment. The role will work closely with external manufacturing partners and cross-functional teams to support product disposition, batch release, investigations, change controls, and ongoing quality compliance.

Key Responsibilities

• Manage quality activities supporting commercial finished products, with a focus on small-molecule products.
• Review executed batch records and work with external manufacturing partners to resolve quality-related comments.
• Evaluate change controls, investigations, OOS/OOT events, and lot genealogy to support product disposition.
• Perform batch release activities and provide GMP release and disposition strategies.
• Provide quality 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.
• Provide support for audit and inspection preparation and post-inspection activities.
• Lead cross-functional quality projects and collaborate 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.

Qualifications

• Bachelor’s degree in a scientific or allied health field preferred.
• 5+ years of relevant Quality Assurance/Quality Management experience.
• Strong small-molecule pharmaceutical experience is required.
• Experience supporting commercial finished goods, drug product, or commercial manufacturing.
• Hands-on experience with batch release/disposition, deviations, investigations, OOS/OOT, CAPA, and change controls.
• Strong knowledge of GMP/GDP and GxP requirements.
• Experience working with external manufacturing partners/CMOs preferred.
• Strong communication, leadership, problem-solving, and project management skills.

Compensation (MA Pay Transparency):

• Estimated hourly range: $75–$85/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.