Compliance Manager

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Job description

An exciting new opportunity has arisen in London for a Compliance Manager to join a global leader in bringing new solutions to patients for the detection, prevention, and treatment of blood clots.
Please note that to be considered for this role you must have the right to work in this location.
*Key Responsibilities: *

* Developing and implementing a quality policy, defining and mapping quality processes.
* Implement a process for identifying quality needs and developing/modifying SOPs, policies and guidance to address any gaps.
* Performing quality checks on all aspects of the clinical research activities performed, ensuring appropriate document management and control.
* Investigating and classifying reported Quality Issues.
* Facilitation of root cause analysis sessions with study teams.
* Developing and implementing corrective and preventative action plans in conjunction with study teams.
* Providing guidance to study teams on operational quality, risk and regulatory and legislative compliance.
* Providing support to external client audits and regulatory inspections.
* Revising procedures, reports etc. periodically to identify hidden risks or non-conformity issues.
* Assessing the business's future ventures to identify possible compliance risks.
* Keeping abreast of regulatory developments within or outside of the company as well as evolving best practices in compliance control.
* Preparing reports for senior management and external regulatory bodies as appropriate.
* Supporting staff training and engagement in company Quality Management System.
*Requirements:*

* At least 4 to 5 years' experience in a similar role in a Clinical Research Organization or Pharmaceutical business.
* Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
* Knowledge of maintaining and improving quality systems and procedures.
* Prior experience in a Quality role with knowledge of performing Quality checks or audits of data.
* Exposure to client audits and regulatory inspections, ideally in a Quality role.
* A demonstrated commitment to quality in a regulated environment.
* Ability to work independently, with minimal supervision, and be confident to make decisions and escalate accordingly.
* Exceptional customer services skills to both internal and external stakeholders.
* Proven clinical trials project management experience.
* Life science or other relevant degree.
*Apply now*:
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.