QA Operations Lead, GMP Manufacturing & Compliance

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 120,000 - 190,000; Full time

Job summary

Abzena seeks a Supervisor, Quality Operations to lead day-to-day QA oversight for GMP manufacturing of intermediates and drug substances. You will direct QA personnel, ensure compliant execution of on-floor support, review documentation, and drive batch disposition activities.

The role partners with Manufacturing, Analytical Services, and other Quality functions to maintain inspection readiness, data integrity, and continuous improvement across site Quality Operations.

Qualifications

• Bachelor’s degree in science, engineering, or related discipline.
• 7–10 years of GMP-biopharma QA/Operations experience.
• Proven leadership and ability to coach teams.
• Strong knowledge of GMP regulations (US/EU) and 21 CFR.

Responsibilities

• Supervise and develop QA personnel; set priorities and training.
• Coordinate daily QA coverage for GMP manufacturing and on-floor oversight.
• Provide direction for quality events and investigations; escalate as needed.
• Review batch records, logbooks, data, and GMP documents.
• Review and approve SOPs, forms, protocols, and quality records.
• Plan workload to meet schedules and dispositions.
• Monitor quality data and trends to identify risks.
• Maintain inspection readiness and support audits.
• Lead continuous improvement, lean, tech transfer initiatives.
• Oversee environmental monitoring data and trending.
• Support document control, training, audits, and environment monitoring.
• Promote culture of quality and integrity.

Skills

Leadership

GMP knowledge

Quality assurance

Problem solving

Communication

Education

Bachelor’s degree in science/engineering

Tools

GMP documentation systems

Job description

Abzena seeks a Supervisor, Quality Operations to lead day-to-day QA oversight for GMP manufacturing of intermediates and drug substances. You will direct QA personnel, ensure compliant execution of on-floor support, review documentation, and drive batch disposition activities.

The role partners with Manufacturing, Analytical Services, and other Quality functions to maintain inspection readiness, data integrity, and continuous improvement across site Quality Operations.