Sr Dir, Clinl Qual Assurance

Job Title: Senior Director, Clinical Quality Assurance

Location: Ireland, Dublin

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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 will 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.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture -one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career -both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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