Senior Quality Systems Leader - GMP and Training

eGenesis; Cambridge (MA); On-site; USD 107,000 - 139,000; Full time

Job summary

eGenesis, a Cambridge-based biotech company, is hiring a Senior Quality Systems Specialist to bolster QA across GMP manufacturing and testing. The role reports to the Associate Director of Quality Systems and requires cross-functional collaboration across the organization, located in Cambridge, MA.

You will drive quality processes, manage deviations and CAPAs, oversee documentation and training programs, and contribute to quality metrics and regulatory compliance in a fast-paced environment.

Qualifications

• Bachelor’s degree in a scientific or operational discipline relevant to life sciences or biopharma with 5+ years combined of quality system management experience.
• Non-degreed candidates with 7+ years combined GLP/GMP quality systems experience will be considered.
• Knowledge of Quality Management Systems (QMS), CAPA processes, and audit procedures.
• Familiarity with ISO, FDA, cGMP regulations and standards.
• Strong analytical, problem-solving, and communication skills.
• Proficiency in using QA software tools and electronic Quality Management Systems (eQMS) is a plus.

Responsibilities

• Developing, implementing, and maintaining processes to support QA oversight for manufacturing of material for clinical studies.
• Initiate, support and manage deviations and CAPAs ensuring timely closure across all sites.
• Administer the Electronic Laboratory Notebook for issuance and execution of Batch Records and Test Methods.
• Manage documentation (archival of records, document change controls).
• Coordinate organization training, manage training matrices, and develop the Training Program.
• Participate in cross-functional teams to resolve quality issues impacting manufacturing.
• Develop, trend, and report Quality Metrics for the area of responsibility.
• Support policy, process, procedures, and controls to conform to cGMP and regulatory guidelines.
• Provide QA support to Development, Manufacturing, QC, and other cross-functional teams.

Skills

Quality management knowledge

CAPA processes

Audit procedures

Analytical skills

Communication skills

eQMS proficiency

Education

Bachelor’s degree in life sciences/operational discipline

Non-degreed with 7+ years GLP/GMP quality systems

Tools

Qualio

Veeva

Benchling

eQMS tools

Job description

eGenesis, a Cambridge-based biotech company, is hiring a Senior Quality Systems Specialist to bolster QA across GMP manufacturing and testing. The role reports to the Associate Director of Quality Systems and requires cross-functional collaboration across the organization, located in Cambridge, MA.

You will drive quality processes, manage deviations and CAPAs, oversee documentation and training programs, and contribute to quality metrics and regulatory compliance in a fast-paced environment.