Quality Assurance Manager - Cincinnati, OH

Job Description The Quality Assurance Manager is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, cosmetics, combination products and biologics. The role supports the strategic direction to ensure business objectives are met and translates strategy into tactical objectives to deliver strategic plans and regulatory updates. The manager ensures that all product, process or system related quality activities from raw material inspection through shipment of the final product are in compliance with corporate and governmental regulations. Provides direction to staff of professionals, including hiring, setting performance expectations, feedback and staff development. Directs the development of quality policies that meet both regulatory and company requirements. Maintains expertise on FDA, EMA, ICH and other regulatory bodies. Provides compliance leadership to the manufacturing site. Interfaces directly with FDA and other regulatory agencies and customers during inspections. Performs assessments to determine compliance to processes and regulations, identifies potential gaps, and implements improvements within the quality system. Reviews and approves deviation investigations, driving reduction in quality events through robust CAPA. Compiles, analyzes and communicates significant quality or compliance metrics to senior management. Establishes programs to promote quality awareness and compliance. Qualifications Minimum education: High School/GED. Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred. 8+ years’ experience in quality assurance, quality oversight or relevant experience. Leadership of technical professionals and in leading cross‑functional teams. Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations. Familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products. Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products. Experience working in both team setting and independently; works well with manager guidance while able to manage own time. Strong oral and written communication skills needed. Excellent interpersonal skills a plus. Can lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives. Pay Pay Range: $109,500 - $208,500 USD. Location Cincinnati, Ohio. #J-18808-Ljbffr VetJobs