Quality Manager/Lead

PredictImmune Ltd

Closing Date: 30/07/2022

PredictImmune is a global biotechnology company. Our technology is the result of over 15 years’ research at the University of Cambridge and guides personalised treatment of patients with immune-mediated diseases.

We are developing tools to enable better disease management and an improved quality of life for patients with chronic diseases including inflammatory bowel disease (IBD) and multiple sclerosis (MS). Our first product – PredictSURE IBD™ – a prognostic test for both Crohn’s disease (CD) and ulcerative colitis (UC) is now available.

We are seeking to recruit a Quality Lead/Manager, who has significant medical device experience, to join our Product Operations team. You will be supporting the Executive Director of Product Operations whilst working in close collaboration across the entire company, strong communication skills are therefore essential.

Objectives of the Role:

• Supporting product life cycle of IVD’s with regards to all quality matters under the direction of the Executive Director of Product Operations.

• Management of the Quality Management System

• IVDR Responsible person, subject to appropriate experience and knowledge.

• Act as the management representative for the ISO 13485 Quality Management System and take responsibility for Notified Body and Competent authority engagement.

• Support in the preparation, maintenance and review of IVD product technical files.

• Support in the implementation of the company’s regulatory compliance strategy and development of new products.

• Be a key player in driving continuous improvement of the companies QMS.

Key Responsibilities:

• Maintain and Continually improve the Quality Management System

• Support the Executive Director of Product Operations by ensuring that company products comply with regulations in all registered territories.

• Responsible for Product release to market.

• Support in the preparation of IVD technical files.

• Provide leadership at regulatory/customer inspections

• Ensure timely support with regards to all QMS processes, to meet Product support and development deadlines.

• Additional duties and other assignments may be determined by executive management of the Company.

Qualifications & Training:

ESSENTIAL

o Educated to degree level in Life Sciences or equivalent. The need for the qualification may be substituted for substantial hands-on experience in Quality System (ISO 13485)

DESIRABLE

o BSc or equivalent in a Life Science subject with additional Quality training or qualification and/or good understanding of EU, UK and US regulatory requirements.

Experience:

ESSENTIAL

o At least 3 years working experience in Quality Assurance role for an IVD manufacturer selling to the EU market.

o Demonstrate a clear understanding of ISO 13485:2016 and the directives/regulations for CE marking. Must have had experience in managing a significant number of QMS elements.

DESIRABLE

o 5 years + QA experience working for an IVD manufacturer marketing product in EU, US and other regions.

o Experienced leader/manager of ISO13485:2016 QMS

o Experienced in working/engaging with Notified bodies & regulators (i.e. lead inspections) and the preparation of high-quality regulatory dossiers.

o Experience in Medical device software development also desirable.

Skills:

ESSENTIAL

o Excellent organisation skills – able to manage multiple tasks to deadlines, think on your feet to solve problems and maintain a high level of accuracy, even in a changeable work environment.

o Trained ISO 13485:2016 Internal auditor.

o Good numeracy, literacy and IT skills (i.e. Microsoft Office and able to learn new systems quickly).

o Strong communication and interpersonal skills (in written and spoken English), able to relate to colleagues and customers at all levels and navigate cultural differences with ease.

DESIRABLE

o Trained ISO 13485:2016 / ISO 9001 Lead auditor, with experience of auditing suppliers.

o Efficient administration and management of quality and regulatory technical documentation. Proficient user of associated software.

o Experience of using EU Regulatory registration systems.

o FDA experience.

Knowledge:

ESSENTIAL

o Working Knowledge and experience in ISO 13485:2016, medical device and in-vitro diagnostic directives/regulations.

DESIRABLE

o Experience with IVDR.

o Knowledge of US regulatory process for medical devices would be advantageous.

o Experience with similar devices to those manufactured by PredictImmune i.e. PCR tests

o Risk Management experience ISO 14971, FMEA…

o Good working knowledge of UDI and other labelling requirements.

o Assisting with Clinical Evaluation, Post Market Surveillance and Vigilance activities with devices on the market

Attitude:

ESSENTIAL

o Proven capability of working effectively, applying initiative and following set procedures, but also aware of when a problem needs to be escalated.

o Proactive in identifying and investigating issues and presenting potential solutions.

o Team player but also happy to work autonomously with minimal supervision.

o Able to handle multiple tasks effectively.

DESIRABLE

o Willingness to learn, develop and take on more responsibility i.e. develop regulatory knowledge.

What you’ll get in return

PredictImmune offers a competitive salary and benefits package including; Private Health Insurance, Life Insurance and a Pension scheme.

If you feel you have got what it takes to join a vibrant and dynamic small company, then we would love to hear from you. Please send your CV and covering letter to: careers@predictimmune.com mentioning our reference: JOB-2022-01 in the subject line.