Vice President Quality Assurance

Barrington James; Illinois; Hybrid; USD 250,000 - 340,000; Full time

Job summary

A biopharmaceutical organization is seeking a VP Quality Assurance to lead the global quality strategy and ensure robust systems across development and commercialization phases. This critical role involves leading the Quality team, embedding a culture of compliance, and engaging with regulatory authorities. The ideal candidate will have over 15 years of experience and a strong understanding of quality systems in FDA-regulated environments. The position is based in Chicago with a requirement to be onsite 3 days a week.

Qualifications

• 15+ years of progressive Quality leadership experience in FDA-regulated environments.
• Strong expertise in Quality Development.
• Deep understanding of global cGMP and associated quality systems.
• Deep understanding of global cGMP and GCP/GLP quality systems.
• Experience engaging with regulators and leading audits/inspections.
• Strategic yet hands-on leader with a culture of compliance and operational excellence.
• Experience overseeing internal operations and external manufacturing/lab partners.

Responsibilities

• Set strategic direction for all Quality activities across product programs.
• Embed a culture of quality and compliance.
• Lead and develop the Quality team.
• Collaborate with C-suite and board on major quality decisions.
• Design scalable quality systems that grow with the organization.
• Ensure regulatory readiness across evolving requirements.
• Oversee quality for development, manufacturing, and distribution including CMOs.
• Establish and manage Quality Agreements with suppliers and labs.
• Ensure compliance with GxP incl. GLP, GMP, GCP, GDP.
• Serve as regulatory liaison with FDA and global authorities.
• Drive cross-site harmonization of quality processes and standards.
• Advance continuous improvement through risk management and staff development.

Skills

Quality Development

Strategic leadership

Regulatory compliance

Risk management

Risk management

Education

Advanced degree in a scientific or engineering field

Job description

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 [e-mail].