The Vice President (VP) Quality Control (QC) provides strategic and operational leadership for the Quality Control organization and is responsible for ensuring the integrity, reliability, and regulatory compliance of analytical testing supporting the development and commercialization of the Company’s product portfolio, including its lead program SAB‑142.
As the Company advances toward commercialization and expands the use of outsourced manufacturing and testing, the VP QC will design, implement, and oversee a comprehensive analytical control strategy spanning internal laboratories and external contract development organizations, manufacturing, and testing organizations (CDMOs/CRO’s/CTLs). This role ensures analytical methods, testing programs, and laboratory systems are phase‑appropriate, compliant, inspection‑ready, and capable of supporting late‑stage clinical development, regulatory submissions, and commercial supply.
The VP QC partners closely with Technical Operations/CMC, Quality Assurance, Regulatory Affairs, IT and other cross‑functional teams to enable effective technology transfer, analytical method lifecycle management, and product release testing strategies for plasma‑derived antibody products. The position plays a critical leadership role in preparing the organization for BLA submission, regulatory inspections, and commercial readiness.
Key Responsibilities (Include but not limited to):- Develop and execute the Company’s global analytical control strategy to support clinical development, regulatory filings, and commercial manufacturing.
- Provide leadership and oversight of Quality Control operations including analytical chemistry, microbiology, stability programs, and raw material testing.
- Oversee analytical testing conducted internally and externally and directly manage contract testing laboratories and CDMOs ensuring timelines and deliverables are met.
- Establish and maintain governance models for external laboratory oversight, including performance monitoring, deviations, investigations, CAPAs, and data integrity.
- Lead analytical method lifecycle management activities including development, validation, tech transfer, and continuous improvement through and beyond BLA.
- Lead the development and execution of a global commercial analytical assay reduction strategy, ensuring alignment with FDA CBER expectations for risk‑based, lifecycle‑managed control strategies and EMA and MHRA requirements for comparability, post‑approval change management, and variation classification, while maintaining compliance, inspection readiness, and uninterrupted commercial supply.
- Provide QC leadership for our analytical assay technology transfer of analytical methods to and from contracted testing partners.
- Lead and collaborate with cross-functional analytical assay development teams assisting in technical oversight and effectively tech transfer of developed analytical assays into QC.
- Oversee stability programs supporting clinical development, BLA submissions, and commercial shelf-life claims.
- Ensure compliance with global cGMP regulations and applicable regulatory expectations (FDA CBER, EMA, MHRA, and other health authorities as applicable).
- Serve as the primary QC representative for regulatory inspections, audits, and health authority interactions.
- Maintain signature authority for QC records and documentation including Certificates of Analysis.
- Partner closely with Technical Operations, Manufacturing, Regulatory Affairs, and Quality Assurance to ensure end-to-end manufacturing and analytical readiness for commercialization.
- Build, lead, mentor, and develop a high-performing QC team and commercial QC testing laboratory while maintaining analytical drug product release testing for future clinical development programs.
- Develop and manage QC operating and capital budgets and provide clear, data‑driven updates to the executive leadership team on QC performance, risks, resource needs, and budgetary forecasts
Qualifications:- PhD or MS in Chemistry, Biochemistry, Microbiology, or related scientific discipline.
- Minimum of 15 years of progressive leadership experience directing Quality Control functions in the biopharmaceutical industry.
- Demonstrated experience supporting biologics development through late‑stage clinical development and commercialization; direct experience supporting BLA submissions highly desirable.
- Deep expertise in analytical method development, validation, and lifecycle management for complex biologic products.
- Proven experience overseeing analytical activities at CROs/CDMOs and external contract laboratories.
- Strong people leadership skills with a track record of building, mentoring, and leading high-performance QC organizations.
- Experience supporting regulatory submissions, inspections, and interactions with global health authorities..
- Experience with plasma‑derived products, antibody therapeutics, or complex biologics is highly desired.
- Experience interacting with FDA CBER, EMA, MHRA, and other global regulatory agencies is preferred.
- Professional certification (ASQ, SQA) is desirable but not required.
Supervisory Responsibilities:This position supervises others.
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 regularly lift up to 10 pounds. Specific vision abilities required by this individual include close vision, peripheral vision, and the ability to adjust focus.
Working Environment and Travel:Duties will typically be performed in a home office environment and occasionally in normal laboratory and BSL2 laboratory environments. Extended hours including evenings, weekends and holidays can be expected based on business demands.
Periodic business travel to SAB partner CDMO and other locations is expected.
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