Quality Control Specialist

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

What will you be doing?

• Participates in several of the following core GMSA global initiatives and assumes varying degrees of project leadership
• Leads projects to create, maintain, review and train on Standards
• Applies project charters, project plans, and risk planning to all Standard initiatives
• Collaborates with regions and countries to ensure alignment between GMSA and local Medical Affairs Standards, as appropriate
• Reviews Standards on a routine basis and revises Standards, process maps, forms, templates, guidelines, and supporting documentation when appropriate to ensure compliance with regulatory requirements
• Ensures periodic review of Standards per the divisional SOP of SOPs
• Adheres to the GMSA QMS continuous improvement methodology and supports efforts to maintain and improve Standards over time
• Monitors the impact of any business process or regulatory changes on Standard documentation and makes the appropriate recommendation
• Manages reported quality issues and supports audits, assessments, and inspections

Qualifications:

• Bachelor’s degree in life sciences, business, or healthcare + 5 years of relevant Medical Affairs experience (e.g., Standards Alignment, Medical Operations)
• Experience working within regulations and compliance requirements 
• Experience as a member in cross-functional, global initiatives in a complex matrix
• Strong decision-making, problem-solving, and analytical skills, with ability to innovate with practical solutions for complex issues
• Ability to work independently while escalating risks and issues as appropriate
• Proficiency with Microsoft Office Suite (WORD, Excel, PowerPoint)

• Bachelor’s degree in life sciences, business, or healthcare + 5 years of relevant Medical Affairs experience (e.g., Standards Alignment, Medical Operations)
• Experience working within regulations and compliance requirements 
• Experience as a member in cross-functional, global initiatives in a complex matrix
• Strong decision-making, problem-solving, and analytical skills, with ability to innovate with practical solutions for complex issues
• Ability to work independently while escalating risks and issues as appropriate
• Proficiency with Microsoft Office Suite (WORD, Excel, PowerPoint)

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.