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.

Requirements 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