Quality Assurance Lead

Albus Health; Oxford; On-site; GBP 50,000 - 80,000; Full time

Job summary

A growing healthtech company in Oxford is looking for a Quality Assurance Lead to manage quality and compliance functions. This critical role involves leading a team, strategizing quality management, and aligning quality with organizational goals. The ideal candidate will have substantial experience in life sciences, regulatory frameworks, and a track record of managing quality systems.

Qualifications

• 6-8 years of experience in a regulated environment, specifically in Medical Devices and GCP.
• Proven track record as a QA Lead in similar scale and complexity.
• Experience in technology-enabled services/software/business processing outsourcing.

Responsibilities

• Lead the quality and compliance functions of the organization.
• Manage and own the quality management system.
• Act as the Management Representative and oversee Management Review meetings.

Skills

Quality Management

Regulatory Compliance

Stakeholder Relationship Management

Leadership

Analytical Skills

Job description

Albus Health is a nocturnal biomarker company spun out of the 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 our 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, requiring us to scale rapidly to deliver new contracts within ambitious timelines and grow to meet industry demands for our products and services.

We are seeking a proactive and highly organized 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 will lead the quality and compliance team and serve as the company’s quality management spokesperson on both strategic and tactical matters related to quality management.

This is a full-time on-site position based at our Oxford office. We will consider 4 days/week and partially remote arrangements for the right candidate.

Key Responsibilities
- Lead the quality and compliance functions of the organization
- Manage and own the quality management system
- Support development of organizational strategies by aligning quality and compliance with company goals
- Sign off on deliverables as per the approval matrix
- Support and guide the team in ongoing development, CAPA/NC activities, training tracking, RFx responses, and continuous improvement activities
- Act as the Management Representative and oversee Management Review meetings

Skills
- Experienced professional with a strong understanding of transforming key quality management functions and processes
- Strategic, analytical, with demonstrable experience in improving quality management disciplines, systems, and processes, including KPIs
- Experience working in both product and service environments
- Skilled in building and maintaining stakeholder relationships
- Strong experience in quality and compliance management within the life sciences domain, including medical devices and CSV/GAMP5
- Subject matter expertise in GCP, information security, and operational experience in life sciences
- Ability to support strategic discussions with the CEO and influence business leadership

Experience
- Proven track record as a QA Lead in a similar scale and complexity
- Deep knowledge of regulatory frameworks and compliance requirements for pharmaceutical trials and medical devices
- Experience in technology-enabled services/software/business processing outsourcing and related sectors
- Demonstrated success in enhancing quality management and business controls
- 6-8 years of experience in a regulated environment (Medical Devices, CSV/CSA/GAMP)
- Experience in leading change and preparing teams for adaptation

About You
- High-caliber leader who motivates and inspires teams
- Effective communicator with stakeholders at all levels
- Capable of leading teams and working independently on projects
- Proactive, entrepreneurial, and pragmatic
- Skilled in change management and stakeholder engagement
- Able to develop and manage teams effectively