This a Full Remote job, the offer is available from: Europe, European Union, EMEA, Poland

Audit Operational Specialist

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 provides support of the Quality Management lifecycle workstream, monitoring the compliance of R&D GMP suppliers

What You Will Do:

You will contribute to quality assurance and compliance activities, taking responsibility for your deliverables and working collaboratively.

Key responsibilities include:

• Primarily focuses on supplier quality management, compliance, and quality assurance support
• Manage Supplier Notifications of Change (SNCs), supports New Supplier Requests (NSRs) and supplier audits, ensures quality records are completed on time and remain inspection-ready,
• Proactively identifies and mitigates risks, monitors key quality metrics
• Medical Device Batch Release activities
• Supports executions of GMP audits and supplies identification and selection process
  

Your Profile:

You will bring relevant quality assurance and compliance experience, along with the following qualifications and skills.

Required qualifications and experience:

• 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.

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

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