Summary: Avania Clinical is seeking a Quality Manager to strengthen and scale their Quality Management approach, focusing on risk management, standards, and consistent execution. Highlights: 1. Strengthen and scale Quality Management approach 2. Lead interactions with external auditors and client audits 3. Drive inspection readiness and proactive quality management Avania Clinical is a leading contract research organization (CRO) that offers exciting career opportunities for professionals in the clinical research industry. With a global footprint, a diverse range of therapeutic areas, and expertise in supporting medical device and MedTech solutions, Avania Clinical provides a dynamic and rewarding work environment that fosters growth, innovation, and collaboration. Join our team of subject matter experts and contribute to the development of life\-changing medical devices that improve patients' lives worldwide. **Avania are hiring \- Manager, Quality Management** 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 The Quality Manager role will support regional regulatory monitoring, audit execution, and operational governance oversight across European jurisdictions. The Quality Manager will independently execute and support internal and external audits, monitor applicable regional regulatory updates, assess operational impact, support maintenance of regulatory applicability mapping, and provide structured quality oversight The Quality Manager role position ensures continuity of European Quality oversight, sustained inspection readiness, and consistent application of the Quality Management System across EU operation You'll collaborate closely with cross\-functional and global stakeholders to ensure our QMS aligns with applicable regulatory expectations 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** * Support regional regulatory monitoring, audit execution, and operational governance oversight across European jurisdictions. * Lead interactions with external auditors of Notified Bodies as appropriate, ensuring the right materials, SMEs, and narratives are in place—and escalating to leadership when needed * 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 inspection readiness efforts by maintaining a proactive state of preparedness across processes, documentation, and teams * 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 * 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 Manager, Quality Management role . With our continued growth we are hiring talent to join us on our journey and grow with us. **What we're looking for** * Proven experience in both operations and quality management within a CRO/clinical research or other regulated environment, with a strong focus on maintaining inspection\-ready systems and compliant processes * Experience interpreting and applying relevant regulations and standards (e.g., EU/UK requirements such as MDR/MHRA, where applicable), translating requirements into clear, workable internal expectations. * Strong working knowledge of quality management systems (QMS) and a practical, proactive approach to quality—able to identify risk, set standards up front, and influence teams before issues arise (not just audit after the fact). * Confident decision\-maker who knows when to escalate and when to independently move work forward—comfortable operating in a lean team without being a single point of failure. * Hands\-on mindset with the willingness to balance strategy and execution, including rolling up your sleeves to support audit preparation, documentation, CAPAs, and day\-to\-day quality activities. * Excellent stakeholder management and communication skills, able to partner effectively with cross\-functional teams and represent Quality in a client\-facing environment when required. * A seasoned, mature quality professional who is motivated by accountability, continuous improvement, and collaborative teamwork—not someone looking for a "quiet" role with minimal engagement. **What you'll need** * Proven experience in both operations and Quality Management within a CRO, clinical research, or regulated life sciences environment, with strong ownership of a Quality Management System (QMS) and governance activities. * Working knowledge of applicable regulations and standards relevant to clinical research and quality (e.g., EU regulatory environment such as MDR/MHRA awareness, and notified body audit expectations); able to translate requirements into practical, implementable QMS controls. * 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 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 Management—supporting 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 We look forward to receiving your application! \#LI\-DNI