Senior Quality Assurance Specialist

As a Senior Quality Assurance Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Support the development of standards such as procedures, job aids, tools, checklists, etc. and provide training on the conduct of audits, inspections, deviations and CAPA management
• Manage audit, inspection, deviation and CAPA records in the quality management system (i.e., Trackwise)
• Develop innovative presentations and trainings for management
• Utilize project management skills to support special projects with relevant stakeholders in quality and research and development by facilitating meetings, following up on action items, creating and managing documents and ensuring adherence to timelines
• Maintain meeting minutes, manage open actions and ensure successful completion of actions stemming from various meetings (i.e., leadership meetings, project meetings, supplier meetings, etc.)
• Review, analyse and report on trends stemming from audits, inspections, deviations and CAPAs
• Escalate systemic and/or critical findings to the Head of GCP Compliance and CQA management
• Support with logistics during inspections such as request tracking and document coordination Support other compliance support activities, as required

You are:

• BA/BS degree required. Degree in scientific discipline preferred
• Minimum of 2 years of experience in the pharmaceutical, biotechnology or related health care industry
• Minimum 2 years of GCP-related Quality Assurance or relevant clinical trial experience
• Knowledge and experience in GCP, quality, and compliance to conduct responsibilities with input and direction, as needed, from supervisor and other CQA team members
• Skilled in project management and driving results
• Able to develop innovative presentations and trainings
• Collaborative team player with a positive attitude that desires to learn and develop in CQA
• Ability to communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing.
• Able to prioritize and manage multiple projects and demanding timelines
• Attention to detail and ability to analyse complex data

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.