Quality & Compliance Coach - Senior Manager

Job Description: Serve as the onsite Quality & Compliance Coach for the manufacturing facility Lead quality walks and observations to reinforce quality culture and process discipline Coach leaders and subject matter experts on regulatory requirements, quality systems, and compliance expectations Prepare the site for FDA inspections, Notified Body audits, and other regulatory assessments Support Front Room and Back Room audit activities, including inspection strategy and execution Identify compliance gaps and help drive corrective actions related to Warning Letter remediation efforts Partner with Manufacturing, Quality, Regulatory Affairs, Engineering, and Operations teams to improve quality performance Evaluate quality data, audit findings, and operational trends to identify risks and improvement opportunities Drive sustainable QMS practices and strengthen overall system effectiveness Support CAPA investigations, root cause analysis, and continuous improvement initiatives Develop and deliver coaching, training, and mentoring programs to improve site-wide quality competency Promote accountability, ownership, and compliance-focused behaviors throughout the organization Ensure ongoing inspection readiness through proactive assessments and process improvements Support management review activities and quality leadership initiatives