Vice President Quality Assurance

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.

The VP of QA will lead all aspects of Quality Assurance Systems, GxP compliance, clinical and CMC quality oversight, supplier and manufacturing quality, and inspection readiness. This leader will partner closely with QC, CMC, Manufacturing, Clinical Development, Regulatory Affairs, and executive leadership to ensure SAB's programs meet global regulatory expectations and support successful Phase 3 execution and global regulatory filings.

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.

Key Responsibilities (include but are not limited to):

• Quality Leadership & Strategy
  • Define and drive the company's QA vision, strategy, and culture in alignment with SAB's clinical and commercial objectives. This position will be responsible for ensuring 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
  • Ensure robust training programs are in place to support GxP activities across the organization.
  • 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.
  • Ensure compliant and timely release of clinical materials, including oversight of manufacturing and testing of biologics.
  • Evaluate and approve Quality sections of regulatory submissions (INDs, CTAs, BLAs, MAAs) and associated compliance documentation.
• 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.

Supervisory Responsibilities:
This position has supervisory responsibilities.

Education/Experience/Skills:

• 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.

Working Environment and Travel:

• Ability to travel up to 20%, including international travel as needed.
• Normal office working conditions.

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