Lead and oversee all quality operations within a pharmaceutical manufacturing environment by developing, implementing, and maintaining a cGMP-compliant quality system aligned with regulatory standards, customer requirements, and industry best practices.
Responsible for establishing and maintaining a cGMP Quality Management System in compliance with 21 CFR regulations and U.Food and Drug Administration standards. The role ensures product quality, regulatory compliance, and continuous process improvement while leading quality teams and supporting organizational objectives.
Establish and maintain the Quality Management System and ensure ongoing cGMP compliance Audit quality processes, policies, and procedures to maintain operational control Lead investigations of deviations, nonconformance, and customer complaints with root cause analysis Report quality risks, system performance, and regulatory inspection outcomes to leadership Maintain independence in quality review and approval activities
Bachelor's degree in Chemistry, Biology, or a related field
10+ years of management experience in pharmaceutical manufacturing
Expert knowledge of cGMP and regulatory requirements
Experience with Microsoft applications and quality documentation systems
Pharmaceutical industry experience required
Excellent organizational and time management skills Knowledge of quality systems, including change control, deviations, and CAPA processes Ability to manage multiple priorities in fast-paced environments
Director Medical in meridian at Unknown Company
This position is listed as full time and onsite.