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Precision for Medicine
Royston, South East England, United Kingdom
6 days ago


Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping our clients harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

At Precision for Medicine (Labs) we are looking for a talented Quality Assurance Manager. If you have experience in GCLP and have worked in a CRO or research environment .. read on


Day to day:

  • Maintain, develop and adhere to the current UK Quality Management Process.
  • Maintain current knowledge of the relevant GxP and ICH guidance and the requirements for conducting GxP studies/projects.
  • Ensure that UK SOPs and Policies concisely reflect requirements for maintaining GxP compliance.
  • Drive and manage day to day compliance with our QMS, including
    • database accuracy
    • effective management of our controlled documents review process
    • effective management, oversight and follow up for deviations, non-conformances and CAPAs
    • effective engagement with the UK laboratory team to drive proactive management, follow up and timely completion of audit actions
    • supplier qualification to ensure regulatory requirements are met
    • providing support as deputy Archivist
  •  Manage and run the Master Audit Schedule
  • Perform, report and trend-analyse routine internal audits on time and develop additional audits as required (e.g. evidencing management of data integrity processes).
  • Proactive management of Equipment and Computer Systems validation.
  • Lead, report and drive actions from the Quarterly Quality Management Meeting
  • Support management with preparation of QA activities and materials (e.g. client QA questionnaires, RFIs).
  • Prepare for and host external audits
  • Assess and provide responses to questions / issues raised by regulatory agencies and customers
  • Lead ongoing Good Practice efforts for the team, including clear and concise audit feedback, coordinating and delivering ongoing GxP, quality and compliance training as required.
  • Be responsible for generation, protection, maintenance, accuracy and integrity (quality control) of QA-related data and associated metadata.
  • Serve as the site management representative, providing updates to the Director of QA regarding status of the quality system, compliance and performance indicators relating to quality.
  • To be aware and have a working understanding of the responsibilities of other members of the UK team and international QA team.

Initiative based / strategic:

  • Lead integration and harmonisation of UK Operation into the broad Precision for Medicine QMS and collaborate on an ongoing basis with quality staff in other Precision locations to ensure global policies and procedures are aligned.
  • Lead implementation of international CLIA or ISO15189 as required and effectively manage compliance.
  • Work closely with UK Operations Director to lead process improvements, advising and driving the quality / regulatory compliance requirements.
  • Further develop processes for adherence to MHRA data integrity expectations.


  • Keep timely, organised and accurate paper and electronic records.
  • Maintain accurate data entry to all databases & shared systems.
  • Comply with all quality management, regulatory compliance and project management processes (GxP, HTA, H&S), maintaining appropriate training and qualifications.
  • Actively participate in performance review and personal development processes required.




  • Degree in life science discipline 
  • Relevant GxP and audit Training 


  • Experience with Lean Six Sigma / process improvement strategies
  • Implementation of regulatory standard accreditation


  • At least 5 years GLP-based quality assurance experience in the biotechnology or pharmaceutical industry.
  • Previous experience of working within a customer orientated research environment or working with CROs.
  • IT literacy including MS Office components.
  • Project management / process implementation and/or improvement experience.
  • Experience of the regulatory requirements for using and handling human tissue (research and clinical).
  • Experience interpreting and complying with worldwide cGxPs with an emphasis on GLP, GCLP, ICH, ISO and, a working knowledge of CLIA.
  • Engaged with the UK Quality Management landscape (e.g. RQA).


  • An ability to understand the ‘big picture’ and the need to balance and prioritise the demands of quality standards with commercial reality.
  • Excellent organisational skills.
  • Exceptional attention to detail.
  • Persistent in maintaining standards for self and others in a continually changing environment.
  • Team player – available for the team and able to engage and influence to drive compliance.
  • Ability to think clearly, analysing and formulating solutions.
  • Excellent communication skills, both verbal and written, with confident presentation skills.
  • Ability to communicate with, and gain the confidence of, external clients to VP level.
  • Experience of representing a company on an international basis, internally and externally.
  • Assertive with the ability to make tough decisions and implement as appropriate.
  • Able to cope with pressure, and to meet the needs of a dynamic, growing company, and the ever changing needs of the business.
  • Honest and with obvious integrity.
  • Self starter – enthusiastic and energetic.
  • Flexible approach with a ‘can-do’ attitude.

Job Information

  • Job ID: 58777398
  • Location:
    Royston, South East England, United Kingdom
  • Position Title: Quality Assurance Manager
  • Company Name: Precision for Medicine
  • Industry: Biotechnology
  • Job Function: Quality Assurance
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: Degree
  • Required Travel: 10-25%

Please refer to the company's website or job descriptions to learn more about them.

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