Vice President Quality Assurance

VP Quality Assurance I’m working exclusively with a rapidly growing biopharmaceutical organization dedicated to supporting the development and commercialization of complex biopharmaceutical programs. Leveraging a highly integrated network of partners and deep technical expertise, they deliver end-to-end support spanning R&D, Quality, Manufacturing, and Regulatory functions. They are currently seeking a VP QA to define and drive the global quality strategy, ensuring robust, scalable systems are in place across all phases of development and commercialization. Reporting directly to the Chief Technical Officer, this is a critical role in leading and growing the Quality team and Quality Development. Responsibilities Setting the strategic direction for all Quality activities across pharmaceutical, biologic, and combination product programs. Embedding a culture of quality and compliance across internal teams and external partners. Leading an established team of Quality professionals, with a mandate to continue building capability. Collaborating closely with the C-suite and board on major quality decisions. Designing and implementing scalable quality systems that grow with the organization and its pipeline. Ensuring global organizational readiness to meet evolving regulatory and operational requirements. Overseeing quality for development, manufacturing, and distribution, including CMOs and external partners. Establishing and managing Quality Agreements with suppliers, contract labs, and strategic collaborators. Ensuring compliance with international GxP expectations, including GLP, GMP, GCP, and GDP. Serving as the primary regulatory quality liaison with the FDA and global authorities. Driving cross-site harmonization of quality processes and standards. Advancing continuous improvement through proactive risk management, staff development, and system evaluation. Qualifications Advanced degree in a scientific or engineering field. 15+ years of progressive Quality leadership experience within FDA-regulated biopharmaceutical or combination product environments. Strong expertise in Quality Development. Deep understanding of global cGMP and associated GCP/GLP quality systems. Demonstrated success engaging with regulatory agencies and leading audits/inspections. Strategic yet hands‑on leadership style with the ability to foster a culture of compliance and operational excellence. Experience overseeing internal operations alongside external manufacturing and laboratory partners. This position requires being onsite 3 days a week based in Chicago. If you’re interested in learning more, please apply or reach out directly at View email address on click.appcast.io . #J-18808-Ljbffr Barrington James