Since this organisations founding in Europe in the 90's, this leading Healthcare organisation's mission has been to help their clients to accelerate the development of drugs and devices that save lives and improve quality of life. They do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. This innovator offers a full range of consulting, development and commercialisation services from a global network of offices in 37 countries and focus their innovation on the factors that are critical to their clients - reducing time to market, reducing cost, and increasing quality - and their global team of experts has extensive experience in a broad range of therapeutic areas. An exciting opportunity has arisen in this organisation at an exiciting time in its growth for a Senior Director Clinical GCP Quality to lead and develop the organisations Quality Assurance group here at their Corporate Offices in Dublin.
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 the organisations clients to ensure first class support.
- 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 the business are of the highest standard and are in compliance with the requirements of the organisation 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 businesses 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 the business 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.
- 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.
- 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.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.