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 teams and coaching employees.
Strong knowledge of GMP regulations and guidance, including US, EU, and global standards.
Experience with GMP manufacturing oversight and controlled-document review.
Advanced problem-solving skills in a fast-paced environment.
Ability to work independently and manage multiple tasks effectively.
Responsibilities
Supervise and develop Quality Operations personnel, setting priorities and monitoring performance.
Coordinate daily QA coverage for GMP manufacturing with real-time oversight during processing.
Direct quality event management and ensure timely escalation and resolution of issues.
Oversee review of batch records and GMP documentation for accurate batch disposition.
Review and approve SOPs, quality records, and controlled documents.
Plan team workload to align with manufacturing schedules and business priorities.
Monitor quality data to identify risks and opportunities for preventive action.
Benefits
Promotes a culture of quality and accountability.
Supports continuous improvement and operational excellence initiatives.
Encourages respectful communication and adherence to company policies.
Provides opportunities for professional development and training.
Full Job Description
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
About Abzena plc
Abzena is a life sciences group with headquarters in Cambridge, UK and offices in the US and Japan. The company provides technologies and complementary services to enable the development and manufacture of biopharmaceutical products. Abzena's services and technologies are used by a range of companies and academic organisations across the pharmaceutical industry, including small biotech to large pharmaceutical companies. The company's proprietary technologies include composite human antibodies and site-specific conjugation technologies, which enable the development of antibody drug conjugates (ADCs) and other biotherapeutics. Abzena's services include antibody discovery and engineering, immunology services, bioassays, cell line development, and biomanufacturing. The company has a range of partnerships and collaborations with pharmaceutical companies and academic institutions, and has a number of products in clinical development.
