ICON Clinical Research

Sr Dir, Clinl Qual Assurance

Location
Dublin
Salary
Competitive
Posted
22 Feb 2021
Closes
24 Mar 2021
Ref
JR067715
Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Senior Director, Clinical Quality Assurance

Location: Leopardstown, Dublin 18

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry!

Are you one of them?

At ICON, we have an incredible opportunity for an expert Senior Director of Clinical Quality Assurance to join the team in our global HQ in Dublin 18.

The Role

Reporting to the VP of Quality Assurance, you will be responsible for leading and developing the Quality Assurance team ensuring that an effective structure is in place. Working collaboratively with other QA team across the business to ensure consistent quality standards are delivered. Partnering closely with ICON's clients to ensure first class support.

This role will involve travel up to 35%.
  • Build and maintain an effective Quality Assurance function within the region.
  • Lead, develop, grow and manage the Quality Assurance team, ensuring that an effective management structure is in place in the QA Team.
  • Ensure that an effective audit program is implemented, in order to provide assurances that clinical studies managed by ICON are of the highest standard and are in compliance with the requirements of ICON or Sponsor SOPs, study protocols, relevant regulations and guidelines and with ISO 9000 requirements.
  • Provide expertise and leadership in Quality Compliance to the wider organization, and ensure that all personnel are aware of the ICON requirements for quality.
  • Proactively ensure that the ICON QMS procedures are updated in line with changes in laws, standards and regulations and to ensure process improvements, and meet business needs.
  • Provides input/support to operational teams on issue resolution and process improvements.
  • Serves as the division expert on Quality related matters.
  • Provide ongoing feedback to senior management of quality compliance (metrics)
  • Work closely with the QA teams in other regions to ensure consistent quality standards and to foster strong working relationships
  • In conjunction with the Finance department, prepare the QA department budget and ensure effective cost control.
  • Ensure that Sponsor and Regulatory audits are effectively executed and provide support and direction during the hosting of such audits as necessary.
  • Participate in professional development through journal articles and by presenting at and attending conferences and professional meetings.
  • Contribute to the growth of ICON by participating in stand-alone QA services, in collaboration with the business development group, and in line with market opportunities and available resources.
  • Keep the person to whom the Senior Director reports informed of any quality issues within the department/office which require attention.

What you need
  • A Degree within Life Sciences.
  • A minimum of 10 years Clinical experience
  • Strong people management skills/experience
  • A deep understanding of clinical trials and processes involved.
  • An experienced people leader who is always looking to develop and support their team in their careers at ICON.
  • GCP regulatory experience is a necessity for this role as is an Audit background.
  • A strategic thinker who sees critical issues that need to be acted upon.
  • Forward thinking with the ability to see opportunities to improve the QA function.
  • Excellent team member who has the ability to cultivate genuine relationships with our clients.

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