At a Glance
- Tasks: Lead quality assurance and compliance functions in a cutting-edge health tech company.
- Company: Join Albus Health, a pioneering medical technology startup from the University of Oxford.
- Benefits: Enjoy salary, equity options, pension plan, and training opportunities.
- Other info: Be part of a small, dynamic team with exceptional growth opportunities.
- Why this job: Make a real impact in healthcare by ensuring top-notch quality in innovative products.
- Qualifications: 6-8 years in quality management, especially in medical devices and life sciences.
The predicted salary is between 82800 - 101200 $ per year.
Albus Health (www.albushealth.com) is a medical technology spin-out company from the University of Oxford. We have developed Albus Home, a contactless multisensor platform that monitors sleep, vital signs and cough without the patients having to do, wear or charge anything. The product incorporates state-of-the-art sensor technology, with sophisticated signal processing and AI/machine learning algorithms, collecting continuous, objective and accurate physiological data from the patient’s home. Albus Home is available in over 50 countries and has been used to collect over 10 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 medicine.
We are seeking a proactive and highly organised Quality Assurance Manager to join our growing team and lead the quality and compliance function at Albus Health. This is a part-time hybrid/remote position, with the option of onsite presence at our offices in Oxford. This role would report to our Head of QARA.
Key Responsibilities
- Lead the quality and compliance functions of the organisation.
- Manage and own the quality management system.
- Support 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 demonstrable 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-on in medical devices and CSV/GAMP5.
- Subject matter expertise on GCP and information security and operational experience in life sciences industry.
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 structured 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 others 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 lead teams as well as function independently on quality related projects.
- A proactive self-starter with an 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 skills - ability to develop, manage and run a team and work closely with managers.
Stock Option Plan, Pension Plan, Training & Development, Cycle To Work Scheme, Exceptional growth opportunities in a rapidly growing startup.
Quality Assurance Manager employer: Albus Health
Albus Health is an exceptional employer, offering a unique opportunity to work at the forefront of health data technology in a collaborative and innovative environment. With a strong focus on employee autonomy and growth, you will have the chance to take ownership of critical testing functions while enjoying flexible working arrangements in the vibrant city of Oxford. Our commitment to employee well-being is reflected in our generous benefits package, including share options, flexible hours, and regular team activities that foster a supportive work culture.
