Position Summary
The Quality Manager will lead and oversee the Quality function at the site, ensuring compliance with GMP regulations, company global quality standards, and customer expectations.
This role will manage a team of Quality professionals and work closely with cross-functional departments to support the delivery of high-quality clinical and commercial batches.
The ideal candidate brings strong leadership skills, a solid understanding of CDMO business dynamics, and hands-on experience with clinical GMP manufacturing environments.
Key Responsibilities
• Lead and manage the Quality Assurance and Quality Control teams at the site, as well as working with Global Regulatory Affairs for RA topics.
• Ensure compliance with GMP regulations, global quality standards, and customer requirements for API manufacturing.
• Oversee batch release activities, including review and approval of clinical and commercial GMP batches.
• Develop, implement, and maintain Quality Systems (deviations, CAPA, change control, investigations, audits, etc.) to ensure a state of continuous compliance and inspection readiness.
• Act as the primary quality contact for clients, regulatory authorities, and internal stakeholders for the site.
• Support regulatory inspections and client audits; ensure timely and effective closure of observations.
• Collaborate closely with Operations, Engineering, Regulatory Affairs, and Project Management to support manufacturing and technology transfer activities.
• Drive continuous improvement initiatives to enhance quality performance and operational efficiency.
• Manage and develop the Quality team through effective leadership, training, and performance management.
• Contribute to the site's strategic planning as part of the site leadership team.
Qualifications & Experience
• Bachelor's or Master's degree in Chemistry, Pharmacy, Chemical Engineering, or related field.
• Minimum 5 years of experience in Quality roles within the pharmaceutical or chemical API industry.
• Proven experience in a CDMO environment, working with multiple customers and projects.
• Strong experience with clinical GMP batch manufacturing and release.
• Previous experience managing and developing teams.
• In-depth knowledge of ICH guidelines, GMP regulations (e.g., EU GMP, US FDA), and regulatory expectations.
• Excellent communication skills and ability to interact effectively with internal and external stakeholders.
• Strong problem-solving and decision-making skills.
This is an on‑site position based in Chicago, IL. Candidates must reside locally or be willing to relocate domestically. The company cannot provide visa sponsorship; therefore, applicants must already be authorized to work in the United States without current or future sponsorship
