Quality Assurance Manager

About the role

The Quality Assurance Manager is a key member of SAB Biotherapeutics’ Quality Assurance function and is responsible for supporting and maintaining an inspection-ready Quality Management System across SAB’s biologics, clinical, laboratory, and GMP manufacturing activities. This role provides quality oversight for GxP operations, including cGMP, GCP/GCLP, GLP, Good Documentation Practices, and applicable internal quality requirements.

Responsibilities

• Provide day-to-day quality oversight for SAB’s GxP operations, including laboratory, clinical, and GMP manufacturing activities, ensuring compliance with applicable regulations, guidance, internal procedures, approved protocols, and Good Documentation Practices.
• Maintain and improve SAB’s Quality Management System, including document control, deviations/nonconformances, OOS/OOT and complaint investigations, CAPA, change control, quality metrics, and management review inputs.
• Review and approve regulated documentation, including controlled documents, protocols, reports, specifications, forms, batch or production records, laboratory records, investigations, CAPAs, change controls, qualification/validation records, and other GxP documentation for accuracy, completeness, traceability, risk impact, and compliance.
• Promote data integrity, ALCOA+ principles, risk-based quality decision-making, continuous improvement, and cross-functional collaboration.
• Supervise, coach, and develop QA personnel as assigned and perform other quality, regulatory, clinical quality, or compliance-related duties to support SAB’s business and program needs.
• Provide functional leadership to cross-functional team members for assigned quality system activities, including workload planning, training, coaching, performance input, and ensuring timely completion of quality deliverables.

Requirements

• Bachelor’s degree in biology, microbiology, chemistry, biochemistry, pharmaceutical sciences, or a related life-science discipline required; advanced degree preferred.
• Minimum of 5 years of progressive quality assurance, quality systems, manufacturing quality, clinical quality, laboratory quality, or related regulated life-science experience; biologics, pharmaceutical, or clinical-stage biotechnology experience strongly preferred.
• Demonstrated working knowledge of applicable GxP requirements and quality expectations, including cGMP, GCP/GCLP, GLP, Good Documentation Practices, data integrity expectations, deviation/CAPA, change control, supplier quality, audit readiness, and risk management.
• Experience reviewing and approving regulated documentation such as SOPs, protocols, reports, batch or production records, laboratory records, deviations, investigations, CAPAs, change controls, and validation/qualification documentation.
• Experience supporting internal audits, supplier audits, customer audits, regulatory inspections, or inspection-readiness activities preferred.
• Experience with electronic quality systems, document management systems, training systems, or other regulated electronic records preferred.
• ASQ CQA, CQE, RAC, or other relevant quality/regulatory certification preferred but not required.

Skills

• Must be able to write clear, accurate, and inspection-ready quality documentation, including investigations, audit observations, CAPA plans, change control assessments, quality summaries, and management review inputs.
• Must communicate effectively with internal stakeholders, leadership, vendors, auditors, and regulatory representatives.
• Proficient with Microsoft Office applications and applicable electronic quality systems.
• Must be able to interpret technical and scientific information, evaluate quality trends and metrics, assess risk, review data for completeness and integrity, and apply established statistical, mathematical, and scientific principles to support quality decisions.
• Working knowledge of applicable U.S. and international quality expectations, including FDA cGMP regulations, ICH quality and clinical guidance, Good Documentation Practices, data integrity expectations, and applicable clinical, laboratory, and biologics quality standards.

Physical Demands

• Regularly required to walk, stand, and sit.
• Must be able to lift and/or move up to 10 pounds.
• Specific vision abilities required include close vision, peripheral vision, and the ability to adjust focus.
• Will view a computer monitor for long periods of time.

Working Environment

Normal office environment with some exposure to lab areas. The noise level in the working environment is usually moderate.