Hays · 4 days ago
Head of Quality Assurance
Greater Chicago Area
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expHays is seeking a Head of Quality Assurance to lead and oversee the Quality function at their site. The role involves ensuring compliance with GMP regulations and managing a team of Quality professionals to support high-quality clinical and commercial batches.
Information ServicesRecruitingStaffing Agency
No H1B
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
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
Company
Hays
Hays is a leading global professional recruiting group, they are expert at recruiting qualified, professional and skilled people worldwide. It is a sub-organization of Hays plc.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Manu Saigal
Country Manager - India
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