[Hiring] Quality Compliance & Systems Operational Specialist @ICON plc

Role Description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Quality Assurance Specialist II at ICON, you will support the implementation and execution of supplier quality activities for GMP suppliers and provide support of the Quality Management lifecycle workstream, monitoring the compliance of R&D GMP suppliers.

What You Will Do:

• Contribute to quality assurance and compliance activities, taking responsibility for your deliverables and working collaboratively.
• Primarily focus on supplier quality management, compliance, and quality assurance support.
• Manage Supplier Notifications of Change (SNCs), support New Supplier Requests (NSRs) and supplier audits, ensuring quality records are completed on time and remain inspection-ready.
• Proactively identify and mitigate risks, monitor key quality metrics.
• Conduct Medical Device Batch Release activities.
• Support executions of GMP audits and supplies identification and selection process.

Qualifications

• Bachelor's degree in a related field (e.g., Life Sciences, Regulatory Affairs, or Compliance).
• Working knowledge of current Good Manufacturing Practice requirements for the biopharmaceutical and medical device industries.
• Experience in supplier quality management and auditing GMP suppliers (e.g., CMOs).
• Experience with risk management strategies and general project management.
• Proven success in identifying and implementing continuous improvement initiatives.
• Minimum of 5 years professional working experience in the field of healthcare products or related activities such as pharmaceutical or device manufacturing, Quality Control or Quality Assurance, including at least 4 years in GMP Quality or Compliance.
• Experience working in a global organization and effectively collaborating across functions, geographies, and cultures.

Requirements

• #LI-Remote
• #LI-RS1
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.

Company Description

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply.