Compliance Manager

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Job description

*Pop science is delighted to offer an opportunity with one of our partners in Central London who have recently launched a new CRO to add to their continued success within the industry. *
*Uniquely you will have the backup and support of a highly regarded institute as well as a committed and enthusiastic team of colleagues.*
*Due to their continuing success we now require a Compliance Manager to join the growing team.*
*Compliance Manager *required to drive and deliver operational quality and process improvement initiatives, training and compliance across client studies to increase operational quality, efficiency and long-term business success.
* 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 and ensuring appropriate document management and control.
* Investigating and classifying reported Quality Issues.
* Facilitation of root cause analysis sessions with the study teams.
* Developing and implementing corrective and preventative action plans in conjunction with the study teams.
* Providing guidance to the 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

* Desired Skills and Experience: *

* 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

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