Quality Manager

Avania

40d • $130,000

About The Position

As a Quality Manager at Avania, you will play a pivotal role in strengthening and scaling our Quality Management approach—moving beyond post-activity QA checks to proactively partnering with the business on risk management, standards, and consistent execution. You'll lead and support a high-volume audit environment, including client audit hosting and inspection readiness activities, while also performing and delivering billable quality audits (e.g., site audits and mock BIMO).

This role requires a confident, hands-on professional who can make sound decisions, escalate appropriately, and represent the quality function with credibility in front of external auditors. Working with a small, high-impact team and periodic travel as needed, this position offers an opportunity to take meaningful ownership, help reduce single points of failure, and drive quality compliance in a practical, business-enabling way.

Responsibilities

• Lead and host client audits and support ongoing audit readiness activities, including preparation, coordination, and follow-up to ensure timely, thorough responses and sustained compliance
• Drive FDA inspection readiness efforts by maintaining a proactive state of preparedness across processes, documentation, and teams
• Plan and execute billable site audits, including scheduling, conducting audits, and delivering clear, high-quality audit reports with actionable findings
• Conduct or support mock BIMO activities and other readiness assessments to identify gaps early and strengthen quality controls
• Partner with cross-functional stakeholders to shift quality from primarily "after-the-fact" assurance to upfront quality management, including risk-based thinking, setting minimum standards, and advising on compliant execution
• Lead interactions with external auditors as appropriate (e.g., notified body audits), ensuring the right materials, SMEs, and narratives are in place—and escalating to leadership when needed
• Support quality-related system work as needed, including contributing to computer system validation activities (e.g., user requirements, risk assessments, test scripts) and helping improve how systems are adopted and maintained

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed