Senior QA Specialist, Supplier Quality

🔥 6 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 12%

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SAB BIO

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency human immunoglobulin G (hIgG) therapies to treat and prevent immune and autoimmune disorders, with a stated mission to redefine diagnosis and treatment of type 1 diabetes (T1D) through disease-modifying medicines. Founded in 2014 and traded on Nasdaq (SABS) since 2021, SAB BIO uses proprietary genetic engineering and antibody technologies to generate therapeutic candidates without relying on human donors or convalescent plasma. The company has conducted seven clinical trials dosing roughly 700 individuals across multiple therapeutic areas, reporting no patients with serum sickness or neutralizing anti-drug antibodies in its safety and immunogenicity database. Its lead candidate, SAB-142, is aimed at delaying onset and potentially preventing progression of Stage 3 T1D.

📋 Description

• Lead risk-based qualification and requalification of suppliers, service providers, and CDMOs • Manage ongoing third-party quality oversight, including performance monitoring, quality agreements, change notifications, and corrective actions • Maintain third-party qualification records and approved status, including periodic reviews and risk escalation • Manage contractors and consultants conducting third-party audits • Independently plan and conduct audits, prepare reports, and follow up on corrective actions • Lead quality oversight of manufacturing and QC operations, including batch record review, deviations, investigations, risk assessments, change control, SOPs, and cross-functional liaison • Lead quality-driven projects and present quality metrics, training initiatives, and validation documentation reviews • Drive ownership and improvement of change control, CAPA, and document-management systems • Author, review, and approve controlled documents, including SOPs, batch records, and work instructions • Perform batch disposition by reviewing records, testing results, environmental monitoring, CoAs, deviations, and quality-event closures • Inspect and approve raw materials, packaging components, and in-process materials against specifications and CoAs • Provide QA floor support during manufacturing as needed • Mentor junior QA staff as needed • Travel to supplier locations, CDMOs, and company locations

🎯 Requirements

• BS/BA in life sciences • 5+ years of quality assurance experience in a regulated manufacturing environment required • Pharmaceutical or related industry experience highly preferred • Hands-on experience qualifying, auditing, and overseeing GMP suppliers and service providers required • Experience with risk assessments, quality agreements, and corrective-action follow-up • Experience qualifying and overseeing GLP and GCP service providers preferred • Strong communication skills • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook • Ability to present information in one-on-one, small-group, and company meetings • Ability to aseptically gown and practice aseptic behavior in controlled areas • Ability to compile and analyze data using mathematical and scientific techniques • Familiarity with eQMS functionality • Experience implementing an eQMS highly desirable • Self-motivation, initiative, accountability, priority management, and process-improvement orientation • Ability to walk, stand, and sit regularly • Ability to lift and/or move up to 10 pounds • Ability to travel domestically and internationally approximately 50% • Must be eligible to work in the United States (application asks about U.S. and Canadian work eligibility)

🏖️ Benefits

• Equal employment opportunity and anti-discrimination protections • Reasonable accommodations in compliance with the Americans with Disabilities Act of 1990 • SMS/text message updates regarding the job application (with consent)

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