Quality Assurance Manager - Cincinnati, OH

About the role

The Quality Assurance Manager supports the strategic direction to ensure business objectives are met, focusing on quality assurance for various manufacturing processes such as pharmaceutical products, medical devices, cosmetics, combination products, and biologics. This role includes supporting the Document Center, Device QA, Labeling, Validation, Training, Quality Intelligence, Compendia management, and CAPA.

Responsibilities

• Supports the strategic direction to ensure business objectives are met.
• Translates strategy into tactical objectives to deliver strategic plans and regulatory updates.
• Ensures all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
• Provides direction to staff of professionals to include hiring, setting performance expectations, performance feedback and development of staff.
• Directs the development of Quality policies that meet both regulatory and company requirements.
• Maintains expertise on various regulations (FDA, EMA, ICH, etc.).
• Provides compliance leadership to the manufacturing site.
• Provides direct interface with FDA and other regulatory agencies and customers during inspections.
• Performs assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our 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

• 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.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
• Experience working in both team setting and independently.
• Works well with manager guidance while able to manage own time.
• Strong oral (with all levels of management) 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.