Senior Manager, Quality Assurance

illumina

Location: Cambridge
Salary:
Closing Date: 10 February 2020
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WORK PERMIT:
All applicants must be based in the UK and confirm that they are able to prove their eligibility to work in the UK.

Job Description

Ensure the development teams conformance to ISO 13485 and EU IVD regulations

Illumina Laboratory Services, the team who completed the sequencing for the 100,000 Genomes Project, are now entering the next phase to deliver whole-genome sequencing into routine healthcare in partnership with Genomics England and the NHS. A critical aspect of this is ensuring the pipeline we develop meets both evolving customer and regulatory needs. Youll be providing strategic guidance and oversite of quality assurance aspects of the medical test development process and IVD development activities for Illuminas clinical laboratories.

You will also lead the development and maintenance of the quality management processes, for both product and software development activities, in the Illumina Laboratory Services medical laboratory group.

Ideally you will be a strategic thinker with great interpersonal and organisational skills, along with a solid understanding of the application of appropriate standards (13485/14971/IEC 62304/IVD directive/regulations).

Like you, we know the importance of your role and offer you a collaborative and supportive environment in which you are actively encouraged to continually develop your own skills and knowledge.

Youll join a culture fuelled by innovation, collaboration and openness. Illumina Laboratory Services are at the forefront of bringing whole genome sequencing into healthcare, helping change lives by driving adoption of sequencing in the diagnosis of rare disease and emerging cancer applications. Your new colleagues are all deeply passionate about what they do, knowing that our work has the power to improve lives. 

 

Responsibilities will include:

Manage and develop a team of quality professionals that are responsible for the support of software and product development activities

Provide quality leadership and guidance to development in the areas of product and software design, validation and risk management

Ensure that the laboratory is best prepared for EU IVD regulations and that training is provided on quality systems processes

Provide interpretation and guidance on quality standards, regulations and directives and develop procedures to ensure compliance

Liaise with colleagues across sites (California, Cambridge) to ensure a unified approach is taken to quality system processes

Work as part of a wider quality assurance team to ensure the integration of quality system processes for laboratory development and testing activities

Champion quality improvement initiatives and lead 3rd party audits

Preferred background, skills and experience:

Bachelors degree, or equivalent, in an engineering or science discipline; advanced degree preferred

Quality Certification is highly desirable (e.g., CQE)

Multi-year quality assurance experience within a regulated environment (direct experience working in in-vitro diagnostic manufacturing preferred)

Knowledge and experience of applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, ISO 15189, IEC 62304, IVDD, IVDR)

Experience with design controls, risk management, validation and change control

Experience with implementing new or significantly updated processes in an organization

Demonstrable line management experience

Adaptable to fast-paced, dynamic work environment with shifting demands


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