Join an organisation that has won multiple international awards as a great place to work.
Now seeking an exceptional candidate to lead a team of QA managers and work collaboratively across the business.
Reporting to the VP of QA 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.
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
• Ensure that an effective audit program is implemented, in order to provide assurances that clinical studies managed are of the highest standard and are in compliance with the requirements of 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 requirements for quality.
• Proactively ensure that the QMS procedures are updated in line with changes in laws, standards and regulations and to ensure process improvements, and meet business needs.
• Work closely with the QA teams in other regions to ensure consistent quality standards and to foster strong working relationships
• Ensure 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.
• 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.
• 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.