Clinical Quality and Compliance Manager, Open to flexibility

03 Nov 2018
15 Nov 2018
Contract Type

Clinical Quality and Compliance Manager, Open to flexibility

We are looking for clinical scientist with exposure to clinical audits to join our Clinical Unit in Cambridge. The role will support the processes involved in ensuring quality standards for the clinical studies.

You will act as a main point of contact for issues arising from clinical study conduct by:

  • Recruitment
  • Clinical Ward Managers
  • Clinical Development Managers
  • Clinical GMP Pharmacy
  • Clinical Laboratory Teams

This will include management and documentation of issues including e.g. protocol deviations. Escalation of any significant issues to CUC QRM as appropriate

You Will:

  • Support the maintenance of relevant policies, procedures and guidelines so that the compliance status of the Unit is maintained on an on-going basis to meet ICH GCP, GMP, GLP and Ethical and Regulatory requirements.
  • Support the management of all processes that generate CAPA's within the unit.
  • Act as meeting chairperson or backup for all relevant Quality meetings run by the compliance team within the Clinical Unit as applicable.
  • Organise, run and Minute CUC Quality Council meetings.
  • Assist with coordinating the writing and review of all Control Documents specific to the Clinical Unit Cambridge and updating any documents related to SOPs, Equipment procedures s & GUIs.

Key Responsibilities:

  • Actively participate in projects assigned by line manager.
  • Oversight regarding the day-to-day supervision of the CUC Compliance Team and QC checking team to ensure that business timelines are achieved to ensure all processes are compliant in line with GSK values
  • Prioritisation of workload to ensure critical project related deadlines are reached and closeout of CAPA's created by members of the unit.
  • Assist with the designing and implementing training programs that meet the operational and regulatory needs of the staff and the department.
  • Help to create and provide regulatory GCP, GMP and Phase I accreditation training for staff within the Clinical Unit (as required) for e.g. Audit / Inspection readiness training.
  • Assist with the developing, supporting and monitoring overall compliance of the Clinical Unit to include processes and Written standards, and systems
  • Assist with raising awareness of changes to policies and procedures / new policies and procedures that impact the Clinical Unit.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.

If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Closing date for applications: 15th November 2018

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.

Thank you for your interest in this opportunity.


Why You?

Basic qualifications:

  • Educated to A level standard or equivalent.
  • Excellent oral, written and presentation skills.
  • Knowledge and experience working under GxP and FDA regulations.

Preferred qualifications:

  • Educated to Degree level standard of equivalent.
  • Good computer skills beneficial for this role specifically in the use of Microsoft Word & Excel.
  • Possess a familiarity with pharmaceutical technology terminology.

Why GSK?:

At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

Contact information:
You may apply for this position online by selecting the Apply now button.

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