Senior Quality Manager

Position Description:

The Quality Manager will lead and oversee the Quality function at the Morton Grove site, ensuring compliance with GMP regulations, 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.

Role & 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.

Experience & Requirements:

• Bachelor’s or master’s degree in chemistry, Pharmacy, Chemical Engineering, or related field.
• 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
• Minimum 5 years of experience in Quality roles within the pharmaceutical or chemical API industry.