The Supervisor, Quality Operations leads day-to-day QA oversight for GMP manufacturing of intermediates and drug substances. This role directs and develops Quality Operations personnel, while ensuring compliant execution of on-floor support, documentation review, environmental monitoring, and batch disposition activities.
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.
Shift A: 4 x 10, Sun-Weds
Shift B: 4 x 10, Weds-Sat
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.
Qualifications
- Bachelor’s degree in science, engineering, or 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, multi-task, be organized and have good communication skills.
Physical Requirements
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Require working in an office setting where sitting and computer usage would be the norm.
- Capable of accessing the manufacturing areas as needed.
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.