Quality Manager

Quality Manager - GCP

Avania are hiring - Quality Manager - GCP

Salary up to $130,000 + Annual Performance related bonus + Benefits

About the Role

As a Quality Manager at Avania, you will play a pivotal role in strengthening and scaling our Quality Management approachmoving 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.

What You'll Be Doing

• 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 placeand 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

Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply to our Quality Manager role. With our continued growth we are hiring talent to join us on our journey and grow with us.

What You'll Need

• Proven experience in both operations and Quality Management (GCP) within a CRO, clinical research, or regulated life sciences environment, with strong ownership of a Quality Management System (QMS) and governance activities.
• Hands-on audit experience, including hosting and leading client audits and supporting audit readiness activities; ability to confidently interface with auditors and drive timely, effective responses to observations.
• Experience supporting FDA inspection readiness and/or mock inspection activities (e.g., mock BIMO) is strongly preferred.
• Experience conducting and delivering billable audits (e.g., site audits), including planning/scheduling, execution, and clear, defensible report writing; comfortable operating in a delivery-focused model with limited client interaction.
• Ability to shift from "QA after the fact" to proactive Quality Managementsupporting upfront risk management, setting minimum standards, and influencing consistent ways of working across teams and locations.
• Experience with or willingness to learn computer system validation (CSV) activities, such as user requirements, risk assessments, and test script development.
• Strong decision-making and judgment, with the ability to operate independently, escalate appropriately, and reduce single-point-of-failure dependencies in a small team environment.
• Excellent stakeholder management and communication skills, able to collaborate effectively across functions and geographies and build credibility with operations and project teams.
• Willingness to travel periodically as needed to support audits and key quality activities

What We Offer

We offer a collaborative, hands-on quality environment where you can make a direct impact on inspection readiness, audit outcomes, and the evolution from traditional QA to proactive quality management. You'll work closely with a small, global team and partner cross-functionally with operational stakeholders to strengthen processes, risk management, and consistent compliance across locations. Depending on your region, the role includes meaningful exposure to client and notified body audits, with periodic on-site presence and manageable travel as needed.

We provide a clear, structured interview process which will include recruiter conversation, an in-depth technical interview with the hiring manager, and a virtual coffee with the team

Avania takes pride in being an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

We look forward to receiving your application!