Quality Assurance Lead

Albus Health is a nocturnal biomarker company spun out of University of Oxford. We have developed Albus Home, a contactless multisensory platform that monitors a wide range of nocturnal parameters without the patients having to do or wear anything. The product incorporates state of the art sensor technology, with sophisticated machine learning and signal processing algorithms, collecting continuous, objective and accurate physiological data from the patient’s home. Albus Home is certified for use in 25 countries, and has been used to collect over 5 billion data points across a dozen physiological and environmental parameters. Our clients include some of the world’s largest pharmaceutical companies, and partners include some of the most reputed opinion leaders in respiratory medicine and beyond. Our team members have built unicorns in healthtech/biotech and are global leaders in medicine, drug development and healthcare technology. Albus Health is at an exciting growth stage at which we need to scale fast deliver to new contracts within ambitious timelines and grow to meet the industry demands for our products and services. We are seeking a proactive and highly organised Quality Assurance Lead to join our growing team.If you are considering sending an application, make sure to hit the apply button below after reading through the entire description.The Quality Assurance Lead is responsible for leading the quality and compliance function within Albus Health and managing the regulatory risks of the business. The QA Lead leads the quality and compliance team and is the quality management spokesperson for the company on both strategic and tactical matters relating to the quality management.This is a full-time on-site position based in Albus office premises in Oxford. We will consider 4 days/week and partially remote arrangements for the right candidate.Key ResponsibilitiesLead the quality and compliance functions of the organisationManage and own the quality management systemSupports development of organisational strategies within the company by aligning quality and compliance to the strategic thinking and the direction of the companySign off on deliverables as per the approval matrixSupport and guide the team in ongoing development, CAPA/NC activities, tracking training, RFx responses and other continuous improvement activitiesAct as the Management Representative and be responsible for Management Review meetingsSkillsExperienced professional with a significant understanding of how to transform key quality management functions and processes.Strategic and analytical with demonstratable experience in improving quality management disciplines, systems and processes, including KPIs - both within the quality and compliance areas and across the businessExperience of working in both product and services led environmentsExperienced in building and maintaining relationships with key stakeholdersStrong experience of quality and compliance management in life sciences domain; should have worked hands in in medical devices and CSV/GAMP5Subject matter expertise on GCP and information security and operational experience in life sciences industryAbility to support strategic discussion with the CEO, challenge and influence the business leadership to facilitate sustainable growthExperienceA successful track record as a QA Lead with full responsibility in a business of comparable scale and complexity to Albus HealthStrong knowledge of regulatory framework and compliance requirements applicable to vendors supplying to pharmaceutical clinical trials and medical devices including information security standardsExperience in the technology enabled services/software/business processing outsourcing/information services sector and/or adjacent sectorsDemonstrable experience in taking a company to the next level of performance through maximising quality, product and service delivery6-8 years experience of operating in a regulated environment - Medical Devices and CSV/CSA/GAMP5Experience in enhancing quality management xpwpeyx process and business controls and of upgrading a quality and compliance function, including systems and processesExperience in leading change in a structures and sensitive manner and the ability to help prepare and adapt others to change in business and customers needsAbout YouHigh calibre leader who motivates and inspires other to achieve organisational objectives on quality and complianceAbility to communicate effectively and clearly with the business, internal and external stakeholders and help the quality function become a valued part of the businessAbility to lad teams as well as function independently on quality related projectsA proactive self-starter with and entrepreneurial mindset who understands the Albus Health business model and strategic plans. Pragmatic and willing to 'roll up their sleeves'An appreciation for the change management necessary for the business and the ability to articulate that change in a structured mannerA natural communicator who maintains a regular dialogue with key stakeholdersEngaging with employees at all levels enabling them to understand the critical quality factors at their own level of understandingStrong leadership shills - ability to develop, manage and run a team and work closely with managers#J-18808-Ljbffr