QA Operations Supervisor

Abzena Inc. • Bristol, PA

4d

About The Position

The Supervisor, Quality Operations leads day-to-day QA oversight for GMP manufacturing of intermediates and drug substances. The role directs and develops Quality Operations personnel while ensuring compliant on-floor support, documentation review, environmental monitoring, and batch disposition.

The Supervisor plans and prioritizes team workload, provides technical guidance, escalates quality risks, and partners with Manufacturing, Analytical Services, and other Quality functions to resolve issues in real time. The position promotes inspection readiness, data integrity, operational excellence, and continuous improvement across site Quality Operations. The job posting lists two shift options: Shift A is four 10-hour days, Sunday through Wednesday; Shift B is four 10-hour days, Wednesday through Saturday.

Requirements

• Bachelor’s degree in science, engineering, or a related discipline, or equivalent education and experience.
• 7–10 years of relevant experience in a GMP-regulated biopharmaceutical environment, including progressive Quality Assurance or Quality Operations responsibility.
• Demonstrated experience leading people, directing daily work, coaching employees, or serving as a technical lead.
• Strong knowledge of GMP regulations and guidance, including US, EU, and rest-of-world expectations, GDP, 21 CFR, USP, and applicable standards.
• Experience with GMP manufacturing oversight, batch record review, material disposition, batch disposition, investigations, and controlled-document review.
• Sound judgment, risk-based decision-making, and advanced problem-solving skills in a fast-paced manufacturing environment.
• Ability to work well under pressure, independently, multitask, stay organized, and communicate effectively.
• Ability to stand for 1–2 hours at a time and sit for 2–3 hours at a time.
• Ability to work in an office setting where sitting and computer usage are the norm.
• Ability to access manufacturing areas as needed.

Responsibilities

• Supervise, coach, and develop Quality Operations personnel; set priorities, assign work, monitor performance, and support training and qualification.
• Coordinate daily QA coverage for GMP manufacturing and provide real-time on-floor oversight during processing of intermediates and drug substances.
• Provide direction for quality events, documentation issues, and operational concerns; ensure timely escalation, investigation support, and resolution.
• Oversee review of batch records, logbooks, supporting data, and GMP documentation to enable accurate and timely batch disposition.
• Review and approve SOPs, forms, protocols, quality records, and other controlled documents.
• Plan team workload and staffing coverage to meet manufacturing schedules, disposition timelines, and business priorities.
• Monitor quality data and trends to identify risks, recurring issues, and opportunities for preventive action.
• Maintain inspection readiness and support internal audits, regulatory inspections, client audits, and responses to observations.
• Lead or support continuous improvement, lean, technology transfer, and process-efficiency initiatives.
• Oversee environmental monitoring sampling, data trending, document review, and preparation of trend reports.
• Support Quality functions including document control, training, audits, systems, and environmental monitoring, as assigned.
• Promote a culture of quality, accountability, integrity, respectful communication, and adherence to company policies.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager