QA Director

About the Role

As QA Director, you will lead all Quality Assurance activities for a US-based contract manufacturing environment focused on small molecule products. You will set the quality vision, shape quality strategy, and ensure that robust systems, processes, and compliance standards are in place and consistently followed. Partnering closely with senior leadership and cross-functional teams, you will be responsible for driving a strong quality culture, overseeing regulatory inspections, and making sure products and services delivered by the organization’s CMO/CDMO operations meet all applicable regulatory and customer requirements. This is a high-impact leadership role where your decisions directly influence product integrity, patient safety, and the organization’s reputation.

Key Skills and Expertise

• Proven experience in a senior Quality Assurance leadership role, ideally at Director level or equivalent
• Strong background working in CMO/CDMO environments with a focus on small molecule products
• Deep understanding of quality systems, QA processes, and regulatory expectations relevant to pharmaceutical manufacturing
• Track record of building, leading, and developing high-performing QA teams
• Experience overseeing audits and inspections and interacting with regulatory bodies and key clients
• Ability to design, implement, and continuously improve quality strategies and quality management systems
• Strong stakeholder management skills with the ability to influence senior leaders and cross-functional teams
• Excellent problem-solving skills and a pragmatic approach to risk management and continuous improvement
• Clear, confident communication skills with the ability to represent QA at executive level

Why Join

• Opportunity to own the Quality Assurance strategy and make a significant impact at organizational level
• Strategic leadership position within a dynamic CMO/CDMO environment focused on innovative small molecule work
• High visibility role with direct interaction with senior leadership and key external partners
• Chance to shape and embed a strong quality culture and modern QA practices across the business
• Role suited to individuals who enjoy autonomy, accountability, and driving continuous improvement

Location

• Chicago, United States
• Specific working arrangements (remote, hybrid, or on-site) to be discussed during the interview process