Vice President Quality Assurance

About the role

The VP of QA is a key executive leader responsible for building, scaling, and overseeing SAB’s global Quality Assurance organization as the company advances from late-stage clinical development toward commercialization. Reporting to the Senior Vice President of Regulatory Affairs & Quality Assurance, this role provides strategic leadership across GxP functions, ensures compliance with FDA, EMA, MHRA, and ICH requirements, and drives a culture of quality across the company.

Note: This is an hybrid role requiring 2-3 weeks onsite initially in Sioux Falls, SD. After the first 6 months, regular travel to the Sioux Falls location will be required.

Responsibilities

• Quality Leadership & Strategy
• Define and drive the company’s QA vision, strategy, and culture in alignment with SAB’s clinical and commercial objectives.
• Ensure scalability of the QA structure to support transition from pre-commercial to a commercial-ready organization.
• Establish QA objectives, metrics, and governance to ensure cross-functional accountability and operational excellence.
• Serve as SAB’s senior authority on GxP compliance and global regulatory expectations.
• Quality Systems & Compliance
• Oversee development, implementation, and continuous improvement of Quality Systems aligned with US and international regulatory requirements.
• Identify gaps and lead building systems and processes critical to resolve identified gaps to assure “approved on first filing” from the QA perspective.
• Maintain and evolve the Quality Manual, deviation/CAPA management, change control, documentation standards, and data integrity programs.
• GxP Oversight & Product Quality
• Provide leadership across GxP domains including Quality Assurance, Quality Operations, Clinical Quality, Supplier Quality, and Quality Control.
• Evaluate and approve Quality sections of regulatory submissions (INDs, CTAs, BLAs, MAAs) and associated compliance documentation.
• Ensure compliant and timely release of clinical materials, including oversight of manufacturing and testing of biologics.
• Inspection Readiness & Audit Management
• Lead global inspection readiness activities and serve as executive lead during regulatory inspections and audits.
• Oversee internal and external audit programs, including CMOs, CROs, and critical suppliers.
• Ensure timely, compliant responses to regulatory observations (e.g., FDA 483s, deficiency letters) and drive effective remediation.
• Cross-Functional Partnership
• Partner with QC, CMC, Manufacturing, Clinical Development, and Regulatory Affairs to ensure Quality considerations are integrated early into program strategy.
• Define Quality Assurance staffing needs and build a high-performing team capable of supporting late-stage development and commercialization.
• Drive continuous improvement initiatives to enhance efficiency, compliance, and operational maturity.
• Other Responsibilities
• Ensure global GxP compliance across all functions.
• Support lifecycle management and readiness for Phase 3 and commercial scale.
• Perform additional duties as assigned.

Requirements

• Bachelor’s degree in a scientific discipline required; advanced degree (MS, PhD, PharmD) strongly preferred.
• 15+ years of progressive Quality leadership experience in the pharmaceutical/biotech industry.
• Demonstrated success leading Quality organizations through late-stage development (Phase 2b/3) and global regulatory submissions.
• Deep knowledge of global GxP requirements, Quality Systems, and biologics development.
• Must have experience with INDs, CTAs, BLAs, and/or MAAs filings.
• Must have experience with interactions and audits conducted by FDA, EMA, MHRA, and other global authorities in the QA capacity.
• Must have led at least one BLA/MAA submission and at least one audit in the QA capacity.
• Proven ability to lead cross-functional teams and influence at the executive level.
• Experience managing CMOs, CROs, and external partners.
• Strong communication skills, attention to detail, and ability to drive change across functions.
• Commitment to operational excellence and continuous improvement.
• Ability to travel up to 20%, including international travel as needed.

Qualifications

• Normal office working conditions.

Skills

• Leadership
• Strategic Planning
• Compliance
• Quality Management
• Regulatory Affairs
• Team Building
• Change Management
• Communication
• Attention to Detail
• Continuous Improvement