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QA Manager

09 August 2017

The QA Manager is responsible for establishing and maintaining an effective Quality Management System in accordance with relevant standard(s) including GLCP (Good Clinical Laboratory Practice), UK Human Tissue Act and where applicable design elements of ISO13485. The QA Manager will be instrumental in establishing the epigenetic biomarker discovery and development pipeline as a commercial service and as an independent internal activity.


The QA Manager will be responsible for interacting with and representing Cambridge Epigenetix to the Regulatory and Notified bodies in the key territories (UK, EU, US) and lead the process of obtaining accreditations, certifications and other regulatory approvals as required for Cambridge Epigenetix Services.

Core Responsibilities: 


  • Management of the Document Control System ensuring all documents are held securely and readily available
  • Management of QA Systems including CAPA, Change Control and Design Control
  • Support all Risk Management activities
  • Lead the business in problem resolution and root cause analysis methodology in order to identify corrective and preventive actions and minimise the risk of (re)occurrence
  • Manage the internal audit program to ensure compliance with the QMS and identify areas for improvement
  • Manage the supplier qualification program  to ensure purchased materials and out-sourced services are to the appropriate quality
  • Manage the validation and calibration program for equipment/laboratory computerized systems/software to ensure fitness for purpose.
  • Provide support to the Assay Development Team for method validation
  • Manage the employee training program to ensure effective training is delivered throughout the company
  • Engage with all departments and functional groups within the company to ensure that they are fully engaged with the Quality Management Systems
  • Establish Quality Objectives, monitor performance metrics  for reporting to Senior Management Team

Experience 
This role requires a highly organised Life Science Graduate with quality management qualifications and experience.  Candidates will possess between 5 and 7 years’ experience in this area as evidenced by a relevant Scientific Degree, quality management qualifications and relevant industry experience.

Required:
  • B.Sc. Life Sciences or similar
  • QA Experience in a regulated environment (GCLP, ISO15189, ISO17025, ISO13485 or similar US regulations CLIA, CAP etc.)
  • Understanding of the requirement to achieve ISO 17025
  • Familiar with the requirements of UK Human Tissue Act (HTA)
  • Familiar with Risk Management Tools (eg. FMEA)
  • Quality Management Training/Lead auditor certification
  • Demonstrated ability to lead, direct and influence people
  • Excellent communication and organisational skills

Desirable:

  • Understanding of DNA-based Biomarkers discovery and their development as laboratory developed tests/ In vitro diagnostic devices.
  • Be familiar with the US and EU regulatory pathway for In vitro diagnostic devices as well as with Product Development and Design Control principles
  • Understanding of the role and proven experience of interacting with the UK and EU Notified bodies and US regulators is highly desirable. 

Send your CV to jobs@cegx.co.uk

Salary band: £50 - 60,000