QC Data Manager

Cambridge, UK

The QC Data Manager is responsible for the day to day management, interpretation and presentation of QC data generated by the Breath Biopsy Lab.

Providing a deep understanding of how to present and analyse QC data from both an operational as well as development perspective.  They will be able to review technical data and define new and innovative ways to present and understand trends/issues/non-conformances

Take ownership of the QC data being generated, define and evolve the replication of the data to set world-class standards for the Breath Biopsy Laboratory

Define KPI’s for the QC Team and present this data to relevant teams to help make conclusions and statements about the methods being used

Work closely with the software team to define QC data output parameters

To provide the infra-structure and carry-out the QC processes within the lab to integrate into the Owlstone Medical QMS

 
Key Tasks / Accountabilities

  • Provide the strategic leadership of data-management within Owlstone Medical
  • Develop and implement the data quality program for the Breath Biopsy laboratory in collaboration with management team
  • Working with technical experts and using your knowledge of robust statistical methods, develop approaches for tracking and trending of key metrics and identifying points of intervention to maintain high quality data
  • Provide analytical support to ensure world-class laboratory practice and robust test methods with excellent repeatability that comply with internal SOPs and relevant external guidelines
  • Demonstrate the ability to identify, analyze and report opportunities for improvements and execute solutions
  • Effectively communicate and promote the implementation of data quality program using both written and oral means
  • Drive the adoption of best practice data QC approaches including training presentations and education for staff as required
  • Provide line management to the deputy QC Manager, setting goals and objectives, measuring performance and identifying and implementing relevant training programs
  • Comptencies & Requirements of the role 

Essential

  • Delivery focused, with the drive and enthusiasm to meet objectives in a fast paced and challenging environment
  • Excellent communication skills and ability to manage change on a short-notice basis
  • Competent self-management skills to allow both structured independent lone working, and integration into project development cycles
  • Ability to motivate and manage technical staff
  • Strategic level thinking and ability to plan and deliver on major projects covering multiple-disciplines
     

Person Specification 


Education & Training 

  • You will be qualified to higher degree level in a related discipline
  • Advanced experience working in a pharmaceutical/QC process lab environment
  • Experience of leading a service or clinical operations lab that has operated under GLP or similar rules
  • Knowledge of leading clinical trial process and data management, quality management, and systems applications to support operations

Experience / Knowledge 

  • Working knowledge of thermal desorption gas chromatography
  • Appropriate MS Office skills, statistical analysis software such as matLAB / JMP, EDC, eCRF and preferably IT/SQL
  • Experience in general quality assurance and audit experience
  • The proven ability to lead numerous core study projects
  • A good practical level of line management
  • Demonstrate time management skills and ability to adhere to project productivity metrics and time lines
  • Working knowledge of the relationship and regulatory obligation of the industry with medical products

Skills

  • Ability to motivate and lead staff
  • High attention to detail
  • Flexible approach to changing priorities
  • Ability to work and communicate well while leading a team

About Owlstone

Owlstone Medical has developed a breathalyzer for disease www.owlstonemedical.com.

Every time you breathe out there are hundreds of chemicals on your breath - some are tell-tale markers of disease that our microchip chemical sensor technology is able to detect.

Our vision is to change the way we currently diagnose and monitor serious disease; we aim to become the global leader in the non-invasive detection of cancer, infectious disease and inflammatory disease. The key is detecting diseases earlier, when treatments are more effective, where more lives can be saved. There is no better example than cancer, where if detected early the chances of survival can be as good at 95% but at late stage drop to about 5% - unfortunately there are still far too many people detected at late stage.

The Owlstone group also commercialises a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defence.

Owlstone is an equal opportunity employer and we will consider all qualified applicants for employment without discrimination on any characteristic protected by law including but not exhaustive to; grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status.

Due to the nature of our business, all employment is subject to satisfactory references being obtained and attainment of a Baseline Personnel Security Standard (BPSS) check.

We offer a relaxed, friendly, flexible and international working environment with a great team-spirit. You will be rewarded with a competitive salary package that includes future share options and your work will have a clear impact on people’s lives. If you want to experience the buzz of an expanding company set to succeed on a global scale, Owlstone may be the place for you.


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We are scientists, doctors, engineers and entrepreneurs on a mission to save lives through early detection of disease

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