Quality Assurance Manager
$109,500–$208,500 year
On-siteCincinnati, Ohio, United States
Job Summary
Lead quality assurance support for pharmaceutical, medical device, and biologics manufacturing processes, ensuring compliance from raw material inspection through final shipment. Direct staff on hiring, performance expectations, and development while establishing quality policies that meet regulatory and company requirements. Provide compliance leadership to the manufacturing site, manage direct interfaces with the FDA and other regulatory agencies during inspections, and lead deviation investigations to reduce quality events. Maintain expertise on FDA, EMA, and ICH regulations, analyze compliance metrics for senior management, and drive improvements within the quality system.
Required Qualifications
- Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area
- 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
- 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
- Strong oral (with all levels of management) and written communication skills
- Can lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives
Desired Qualifications
- Excellent interpersonal skills a plus
- Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred
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