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. The position ensures that documentation, procedures, protocols, records, investigations, change controls, CAPAs, supplier activities, and quality decisions are compliant with applicable FDA, EMA, ICH, and internal quality requirements. The Quality Assurance Manager partners cross-functionally with Manufacturing, QC, Clinical Operations, Regulatory Affairs, Facilities, and external vendors to promote a proactive quality culture, regulatory readiness, and continuous improvement.
Duties and Responsibilities: Responsibilities include but are not limited to:-
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.
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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.
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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.
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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.
Supervisory Responsibilities: This position may supervise QA personnel and/or provide functional leadership to cross-functional team members for assigned quality system activities. Responsibilities may include workload planning, training, coaching, performance input, and ensuring timely completion of quality deliverables.
Qualifications:
The successful candidate must demonstrate strong technical judgment, attention to detail, effective communication, sound prioritization, and the ability to apply risk-based quality principles in a regulated biologics environment. The role requires the ability to work independently, collaborate cross-functionally, escalate quality risks appropriately, and maintain inspection-ready documentation and quality system records.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
Education, Experience and Certifications:-
Bachelor’s degree in biology, microbiology, chemistry, biochemistry, pharmaceutical sciences, or a related life-science discipline required; advanced degree preferred.
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Minimum of 5 years of progressive quality assurance, quality systems, manufacturing quality, clinical quality, laboratory quality, or related regulated life-science experience preferred; biologics, pharmaceutical, or clinical-stage biotechnology experience strongly preferred.
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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.
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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.
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Experience supporting internal audits, supplier audits, customer audits, regulatory inspections, or inspection-readiness activities preferred.
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Experience with electronic quality systems, document management systems, training systems, or other regulated electronic records preferred.
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ASQ CQA, CQE, RAC, or other relevant quality/regulatory certification preferred but not required.
Language and Communication 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, and must be proficient with Microsoft Office applications and applicable electronic quality systems.
Analytical and Technical Skills:
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.
Regulatory and Quality System Knowledge:
Working knowledge of applicable U.S. and international quality expectations is required, including FDA cGMP regulations, ICH quality and clinical guidance, Good Documentation Practices, data integrity expectations, and applicable clinical, laboratory, and biologics quality standards. The role is expected to apply these requirements using risk-based, scientifically justified decision-making.
Physical Demands:
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must be able to lift and/or move up to 10 pounds. Specific vision abilities required by this individual include close vision, peripheral vision, and the ability to adjust focus. The employee 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.
ADA:
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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