Quality Assurance Manager

Albus Health; Town of Oxford; Hybrid; CAD 70,000 - 100,000; Part time

Benefits offered by this job

Stock Option Plan

Pension Plan

Training & Development

Cycle To Work Scheme

Growth opportunities

Job summary

Albus Health is seeking a proactive Quality Assurance Manager to lead the quality and compliance function. Part-time hybrid/remote role with onsite option in Oxford.

Report to Head of QARA; responsibilities include managing the QMS, CAPA/NC activities, and regulatory alignment across the business. Ideal candidates will have extensive QA leadership in regulated life sciences, experience with medical devices and CSV/GAMP5, and strong stakeholder management skills to drive continuous improvement

Qualifications

• Significant QA leadership experience in regulated life sciences environments.
• Experience with medical devices and CSV/GAMP5.
• Proven ability to build and maintain relationships with stakeholders.
• Strong regulatory knowledge for pharma, CROs and vendors.

Responsibilities

• Lead the quality and compliance functions of the organisation.
• Manage and own the quality management system.
• Align quality and compliance with company strategy and direction.
• Sign off on deliverables per the approval matrix.
• Support CAPA/NC activities, training tracking and RFx responses.

Skills

Quality leadership

Regulatory compliance

Stakeholder mgmt

GxP/CSV

Life sciences

Info security

Change management

Job description

Position Title: Quality Assurance (QA) Manager

Department: Regulatory

Reports to: Head of QARA

Compensation: Salary + equity options + benefits

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. Our team members have built unicorns in healthtech and biotech and are global leaders in medicine, drug development and healthcare technology.

We’re a small team (10 people) and are growing rapidly, recruiting across several functions. Albus Health is at an exciting stage at which we need to scale fast to meet the rapidly growing industry demand for our products and services. 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 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

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

• Stock Option Plan
• Pension Plan
• Training & Development
• Cycle To Work Scheme
• Exceptional growth opportunities in a rapidly growing startip