ESTEVE · 2 hours ago
Senior Quality Manager
Morton Grove, IL
Full-time
Onsite
Senior Level
5+ years expESTEVE is seeking a Senior Quality Manager for their Morton Grove, IL location. This key leadership role is responsible for ensuring quality and compliance at the U.S. R&D and Production Site, driving quality strategy, and overseeing a dedicated quality team.
Health CareMarketingPharmaceutical
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
Qualification
Required
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
Company
ESTEVE
ESTEVE is a healthcare company in Spain.
1,001-5,000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Lubea
2023-05-17Series Unknown
Leadership Team
Jacob Tolstrup
Chief Business Development Officer
Recent News
Pharma Letter
2026-01-20
Company data provided by crunchbase