Senior Quality Manager
On-site · Columbus, Ohio, United States
Job Summary
Senior Quality Manager to build and lead the quality function from inception, establishing a comprehensive QMS aligned with regulatory standards and business objectives. Lead internal and external audits, regulatory inspections, and CAPA processes; drive continuous improvement using Lean, Six Sigma, or 8D; manage supplier and vendor quality programs; oversee CRO oversight and outsourced activities; partner with clients on regulatory submissions and contract negotiations; mentor and scale a quality team of engineers, auditors, and inspectors; maintain QMS in a regulated environment and liaise with executive leadership on quality strategy and KPIs.
Required Qualifications
- Experience establishing a QMS in a regulated industry
- Strong knowledge of ISO 9001, ICH Q10, GxP, FDA 21 CFR, ISO 13485, AS9100 or equivalent
- Experience working with contract research organizations (CROs) and third-party partners
- Audits management experience including regulatory inspections
- CAPA, root cause analysis, and risk management
- Leadership and stakeholder management skills
- Ability to interact with regulatory bodies
- Familiarity with ITAR/EAR compliance requirements
- Experience in a manufacturing or contract research environment desirable
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