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Quality Manager

2 weeks ago

Guildford, United Kingdom ANGLE Full time

About ANGLE ANGLE is a world‑leading liquid biopsy company commercialising a patent‑protected platform technology that can capture rare circulating tumour cells (CTCs) from blood in a minimally invasive way for downstream analysis. ANGLE’s Parsortix system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood. Parsortix technology comprises a microfluidic device that captures CTCs from blood based on their size and compressibility. CTCs are cancer cells that have detached from the primary tumour and entered the blood circulation and they play a critical role in initiating metastasis. Once harvested the CTCs can be comprehensively analysed to provide a wealth of information about the patient’s tumour, advancing cancer research and potentially personalized medicine. This technology has the potential to deliver profound improvements in clinical and health economic outcomes. ANGLE has established a CTC harvest and analysis service from our UK‑based Clinical Laboratory based in Guildford for customers worldwide. In alignment with company priorities we plan to rapidly expand our services to include molecular profiling of CTCs and ctDNA using digital PCR and NGS to add to our image‑based assays. Join our Team This is an exciting time at ANGLE and our team in Guildford are looking for a Quality Manager. Reporting to the Head of Regulatory the Quality Manager is responsible for managing all aspects of quality (QMS, product process design, quality assurance, software quality assurance) as well as the quality team. The Quality Manager will be responsible for ensuring quality compliance with the necessary requirements and maintaining quality system certification status. At ANGLE we foster a dynamic entrepreneurial approach to translating leading‑edge translational research into clinical diagnostics. We promote a culture of collaboration and shared excellence while encouraging an open and honest exchange of ideas. We are always in search of potential employees who share our vision and want to make a difference. Your submission should describe your background and what you can bring to our team along with attaching your resume. Principal Accountabilities Line manage the quality team. The quality team is responsible for the quality management system design assurance, software assurance, quality engineering, final batch release, product assurance and oversight of validation activities. Act as ANGLE Europe Limited (AEL) deputy PRRC for IVD products made available on the European markets. Act as Quality Management System Representative. Control of the Quality Manual including preparation, revision and execution. Responsible for organising Management Review and compiling and reporting on the performance of the quality system. Oversight of the audit programme (external, internal and supplier). Manage and maintain supplier quality agreements. Management of the product review and release system (batch manufacturing records) including approval of generated certificates of analysis or conformity. Management of changes to product process documentation, equipment, facilities and software. Management of non‑conformance and corrective and preventive action systems. Key participant in the design control process. Communicate the awareness of both customer and compliance requirements throughout the organisation and champion Quality and continuous improvement activities. Ensure that equipment processes and software used in manufacturing, product testing and use in the quality system are validated and suitably maintained. Undertake additional ad‑hoc tasks as required. Qualifications, Experience, Knowledge and Attributes Primary degree or equivalent qualification in a science, engineering, law, medicine or pharmacy. 5‑8 years working experience managing medical device quality management systems with at least one year in IVD manufacturing (ISO 13485 Part 820/QMSR IVDR). Firsthand experience hosting and leading audits by regulatory authorities including notified bodies and/or auditing organisations. Working experience in design and development projects. Knowledge of software requirements (IEC 62304, GAMP5, 21CFR Part 11). Experience with contract manufacturing organisations would be an advantage. Certified lead auditor qualification would be advantageous. Experience of developing and delivering effective training on quality systems and processes. Demonstrated experience of people management. Willingness and ability to collaborate with and influence others in a positive team‑based environment. Must be able to hold others to account as required. An eye for detail and commitment to high quality data. A flexible can‑do approach to the requirements of the job. Job Requirements Due to the nature of the role our requirement is for this position to be Guildford based with flexibility to work from home at the discretion of the Manager. As a member of our highly skilled team you will receive opportunities for training and development and a competitive benefits package. Please let us know if you require disability‑related accommodation during the recruitment process so that we can work with you to meet your needs. Furthermore please be advised that if you submit an application to us for this position your application and personal details will be processed in accordance with our Data Privacy Notice for Job Candidates. Important Notice to Employment Businesses / Agencies ANGLE does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses / agencies are required to contact our ANGLE recruitment team to obtain prior written authorisation before referring any application. In the absence of such written authorisation, any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of ANGLE. ANGLE shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site. Employment Type: Full Time Experience: years Vacancy: 1 #J-18808-Ljbffr