Quality Systems Specialist

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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

• Facilitate implementation, validation, and lifecycle management of GxP computerized systems, including eQMS and related quality platforms • Partner cross-functionally with IT and system owners to ensure systems are configured, maintained, and controlled in compliance with internal procedures and regulatory expectations (e.g., 21 CFR Part 11, Annex 11) • Provide system-related support to business units, including troubleshooting, user guidance, and continuous improvement initiatives • Ensure data integrity principles (ALCOA+) are applied within quality systems and supported across system workflows • Participate in system upgrades, changes, and integrations, ensuring appropriate change control, validation, and risk assessment activities are executed

🎯 Requirements

• BS/BA in life sciences or related field required • Minimum of 2–5 years of experience in a quality assurance/quality control role within a regulated (GMP) environment • Demonstrated level of experience and proficiency with Quality Management Systems (QMS, LIMS, EMS, FMS) • Experience with document control, leading deviation investigations, leading CAPA, and leading change control • Strong knowledge of root cause analysis and quality risk management principles (ICH Q9) • Must have strong communication and cross-functional collaboration skills • Demonstrated proficiency in Microsoft Office software (Word, Excel, PowerPoint, Outlook)

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development