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 .
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