Pop science is delighted to offer an opportunity with one of our partners in Central London who have a rapidly growing CRO to add to their continued success within the industry.

You will have the backup and support of a highly regarded site network, new technology and CRO services, as well as a committed and enthusiastic team of colleagues.

Due to their continuing success we now require a QA and Compliance Manager to join the growing team.

The Compliance Manager is 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:

• Proven experience in a similar role in a Clinical Research Organisation, academic unit 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

Contact Henry for more information

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