Quality Manager

JR United Kingdom; London; On-site; GBP 40,000 - 80,000; Full time

Job description

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IMU Biosciences is a cutting-edge biotech company advancing immune profiling and precision diagnostics through proprietary AI-driven technology. Our platform enables deep immune system characterisation to support the development of next-generation diagnostics and precision medicine applications. By integrating high-dimensional immune data with machine learning, we aim to redefine disease classification and improve patient outcomes. IMU Biosciences partners with leading research institutions, biotech, and pharma companies to bring innovative solutions to clinical practice.

We are a multidisciplinary team of world-leading scientists, software engineers, and statisticians who are passionate about changing the face of medicine by leveraging the power and insight of the immune system. We value diversity, ingenuity, and willingness to take the initiative. We are a series A company, with state-of-the-art laboratories in central London and we are looking for talented, motivated, enthusiastic and experienced individuals to join our team.

Role Overview

We are seeking a highly experienced Quality Manager to manage the quality management system (QMS) ensuring compliance with regulatory requirements and supporting regulatory submissions. The successful candidate should have a strong background in regulatory standards such as ISO 13485, to ensure quality and regulatory adherence in our product development and implementation. They should have experience managing the QMS, conducting internal and external audits and implementing CAPA processes to drive continuous improvement. A solid understanding on risk management (ISO 14971), validation (IQ, OQ, PQ) and GCLP principles is essential. The candidate must possess strong problem-solving skills, attention to detail, the ability to work autonomously and have excellent interpersonal skills to collaborate with cross-functional teams, suppliers and regulatory bodies to maintain product safety and efficacy.

Our laboratory is situated in our head office in Canary Wharf (20 Water Street, Canary Wharf, E14 5GX, UK). In this role you will need to be full time and working at the office in-person, at least 3 times a week, during typical working hours. This role will also require occasional travel owing to international lab setup.

Responsibilities

1. ISO 13485 compliance and quality management system (QMS) maintenance
   1. Ensure full compliance with ISO 13485:2016 standards.
   2. Oversee, manage and improve the QMS, ensuring its effectiveness and continuous improvement.
   3. Keep up to date with regulatory changes and implement necessary adjustments.
2. Training and quality awareness
   1. Provide quality training to employees on ISO 13485 requirements and best practices.
   2. Promote a quality-driven culture of continuous improvement and regulatory compliance within the organisation.
   3. Conduct and ensure GCLP training for personnel handling biological samples and their data.
3. Document control and record management
   1. Develop, maintain, update and control all quality-related documentation including policies and SOPs, ensuring traceability and compliance with ISO 13485.
   2. Oversee and ensure accurate record-keeping of inspections and regulatory submissions.
   3. Participate in risk management activities in accordance with ISO 14971 (Risk Management for Medical Devices).
   4. Identify potential quality risks and implement mitigation strategies.
4. Validation and verification activities
   1. Oversee and support validation and verification of product-related processes, equipment and software used.
   2. Ensure compliance with IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) processes.
5. Process and product quality control
   1. Monitor product-related processes to ensure product quality, consistency and compliance.
   2. Work closely with all teams (especially laboratory, engineering and data teams) to validate processes, resolve quality issues and implement process improvements.
   3. Identify areas for process optimisation and efficiency improvements.
6. Supplier and vendor quality assurance
   1. Conduct supplier evaluations and/or audits to ensure compliance with ISO 13485.
   2. Work with suppliers to maintain supply demand.
   3. Collaborate with suppliers to resolve non-conformances and implement quality improvements.
7. Internal and external audits
   1. Conduct and document internal audits to assess compliance with ISO 13485.
   2. Coordinate and support external audits from regulatory bodies, notified bodies, or customers.
   3. Ensure effective implementation of corrective and preventive actions (CAPA) following audits.
8. Non-conformance and CAPA management
   1. Investigate and track non-conformances (NCs), deviations and out-of-specification (OOS) results.
   2. Lead root cause analysis (RCA) and drive the implementation of CAPA to assess effectiveness of corrective and preventative actions to prevent recurrence.
9. Regulatory and customer complaint handling
   1. Investigate and manage customer complaints and implement necessary corrective actions.
   2. Ensure compliance with regulatory reporting requirements for medical device incidents (e.g., MDR, FDA).
   3. Work with the regulatory affairs team to address compliance issues and maintain market approval.

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope, purpose and grading of the post.

Skills, knowledge and experience

1. Bachelor’s degree (or higher) in biotechnology, biomedical science, biochemistry, immunology or a related field or proven experience working in quality management systems for medical devices.
2. Strong knowledge and hands on experience with ISO 13485:2016 quality management systems.
3. Knowledge of GCLP (good clinical laboratory practice) and relevant regulatory requirement (e.g. FDA 21 CFR Part 820).
4. Hands-on involvement in regulatory inspections and audits from notified bodies or government agencies.
5. Experience in writing, reviewing and implementing quality-related documents, such as quality manual, policy documents and SOPs.
6. Excellent interpersonal and communication skills to liaise with cross-functional teams.
7. Proactive/autonomous.
8. Ability to train and mentor staff on quality procedures and regulatory requirements.
9. Excellent organisational and time management skills, with the ability to manage multiple priorities to meet deadlines under pressure.
10. Able to work flexible hours when necessary.
11. Great problem-solving skills to accurately resolve issues.
12. High level of integrity, accountability and attention to detail.
13. Passion for the life sciences industry and a commitment to scientific innovation.
14. Proven experience working in an accredited laboratory/company.
15. Previous involvement in regulatory submissions, technical file preparation and post-market surveillance.
16. Certifications such as quality management certifications.
17. Experience working with electronic quality management system (eQMS).
18. Some knowledge of human immunology.
19. Experience with flow cytometry.

How to apply

Please send CV and cover letter to Jennie Yang ([emailprotected]) or directly apply on LinkedIn (please include both CV and cover letter with your application).