Quality Systems Manager

About the Role Lead quality-related initiatives (MQRB, CAPA, Regulatory Audits) to ensure regulatory readiness and strong quality system performance. Serve as Backroom Manager during audits and inspections and drive QMS improvements across the organization. What You'll Do

• Develop and maintain timelines and milestones for assigned Quality initiatives, including CAPA processes, CAPA Review Board governance, MSPs, and external audit responses.
• Lead and manage quality elements, ensuring root‑cause analysis, timely/appropriate corrective actions, and verification of effectiveness.
• Define scope, deliverables, timelines, and milestones for QMS elements in collaboration with Quality System team, Program Management, and cross‑functional partners.
• Coordinate external audits and responses; align resources to meet regulatory expectations and project goals.
• Drive continuous improvement of Quality Systems processes and tools; report progress to stakeholders.
• Partner with site Quality, Regulatory, Program Management, Engineering, Manufacturing, and Operations teams, as well as Global functions, to deliver quality projects on time.
• Ensure alignment of projects with QMS requirements and regulatory agency expectations; maintain QMS updates and progress to completion.
• Serve as Backroom Manager during audits and inspections. What We're Looking For
• Experience leading quality system initiatives (CAPA, CAPA Review Board governance, QMS) and coordinating audit programs.
• Strong project management and cross‑functional collaboration skills; ability to manage timelines and deliverables.
• Knowledge of FDA and global regulatory standards and regulatory readiness.
• Analytical and problem‑solving abilities (root‑cause analysis, verification of effectiveness) and continuous improvement mindset.
• Excellent communication and leadership to partner with Quality, Regulatory, Program Management, Engineering, Manufacturing, and Operations. Compensation & Benefits
• Salary: $115,000 – $140,000 per year; 15% STI.
• Hybrid work arrangement: 1–2 days at home.