Quality Assurance Lead
Albus Health
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.
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 Responsibilities
- Lead the quality and compliance functions of the organisation
- Manage and own the quality management system
- Supports development of organisational strategies within the company by aligning quality and compliance to the strategic thinking and the direction of the company
- Sign off on deliverables as per the approval matrix
- Support and guide the team in ongoing development, CAPA/NC activities, tracking training, RFx responses and other continuous improvement activities
- Act as the Management Representative and be responsible for Management Review meetings
Skills
- Experienced 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 business
- Experience of working in both product and services led environments
- Experienced in building and maintaining relationships with key stakeholders
- Strong experience of quality and compliance management in life sciences domain; should have worked hands in in medical devices and CSV/GAMP5
- Subject matter expertise on GCP and information security and operational experience in life sciences industry
- Ability to support strategic discussion with the CEO, challenge and influence the business leadership to facilitate sustainable growth
Experience
- A successful track record as a QA Lead with full responsibility in a business of comparable scale and complexity to Albus Health
- Strong knowledge of regulatory framework and compliance requirements applicable to vendors supplying to pharmaceutical clinical trials and medical devices including information security standards
- Experience in the technology enabled services/software/business processing outsourcing/information services sector and/or adjacent sectors
- Demonstrable experience in taking a company to the next level of performance through maximising quality, product and service delivery
- 6-8 years experience of operating in a regulated environment - Medical Devices and CSV/CSA/GAMP5
- Experience in enhancing quality management process and business controls and of upgrading a quality and compliance function, including systems and processes
- Experience in leading change in a structures and sensitive manner and the ability to help prepare and adapt others to change in business and customers needs
About You
- High calibre leader who motivates and inspires other to achieve organisational objectives on quality and compliance
- Ability to communicate effectively and clearly with the business, internal and external stakeholders and help the quality function become a valued part of the business
- Ability to lad teams as well as function independently on quality related projects
- A 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 manner
- A natural communicator who maintains a regular dialogue with key stakeholders
- Engaging with employees at all levels enabling them to understand the critical quality factors at their own level of understanding
- Strong leadership shills - ability to develop, manage and run a team and work closely with managers