What are the responsibilities and job description for the Vice President Quality Assurance position at Barrington James?
Vice President Quality Assurance
Biopharma - Hybrid, IL
I am exclusively partners with an exciting and expanding Biopharmaceutical organization focused on supporting the development and commercialization of complex biopharmaceutical and combination products. Through its integrated network of partners and specialized expertise, they provide end-to-end support across R&D, Quality, manufacturing, and regulatory functions, helping organizations advance products efficiently from concept to market while maintaining the highest standards of quality and compliance.
The Vice President of Quality will serve as the company’s senior quality leader, responsible for establishing and executing a comprehensive quality strategy across all global operations. This position will ensure that quality systems are designed, implemented, and scaled appropriately through each stage of development and commercialization. The role reports to the Chief Technical Officer and will be instrumental in maintaining reputation for excellence in regulatory compliance and operational integrity.
Responsibilities include:
- Providing strategic direction and leadership for all quality functions across pharmaceutical, biologic, and combination product development programs.
- Building and maintaining a culture of quality and compliance across internal teams and partner sites.
- Leading an established team of Quality professionals, and looking to grow that further.
- Working directly with C-suite and the board for important quality decisions and directions.
- Developing and implementing scalable quality systems that evolve with the company’s growth and product maturity.
- Ensuring resources and organizational structures are in place to meet regulatory and operational requirements globally.
- Managing quality oversight for development, manufacturing, and distribution activities, including contract manufacturing organizations.
- Establishing and maintaining Quality Agreements and oversight mechanisms with suppliers, contract labs, and partners.
- Ensuring compliance with global GxP standards, including GLP, GMP, GCP, and GDP.
- Acting as the primary point of contact for regulatory quality matters with agencies such as the FDA and other international authorities.
- Driving harmonization of quality standards and practices across global operations and external partners.
- Promoting continuous improvement through system evaluation, staff development, and proactive risk management.
- Ensuring that manufacturing and testing sites operate in full compliance with cGMPs, ICH, and WHO guidelines.
Preferred qualifications:
- Advanced degree in a scientific or engineering discipline.
- At least 15 years of progressive leadership experience in biopharmaceuticals or combination product quality management within FDA-regulated environments.
- Strong background in combination products hihgly preferred.
- Comprehensive understanding of global cGMPs and related quality systems for GCP and GLP compliance.
- Proven ability to interact successfully with global regulatory agencies, including leading audits and inspections.
- Strategic and hands-on leader with a collaborative approach and ability to drive a culture of compliance and operational excellence.
- Experience managing quality across internal operations and external manufacturing or laboratory partners.
This position will be 3 days a week onsite in the Chicago area.
Apply today to learn more or reach our directly - rbanton@barringtonjames.com