Quality Compliance & Systems Operational Specialist

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🔥 10 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Support the implementation and execution of supplier quality activities for GMP suppliers • Support the Quality Management lifecycle workstream and monitor the compliance of R&D GMP suppliers • Focus on supplier quality management, compliance, and quality assurance support • Manage Supplier Notifications of Change (SNCs) • Support New Supplier Requests (NSRs) and supplier audits • Ensure quality records are completed on time and remain inspection-ready • Proactively identify and mitigate risks • Monitor key quality metrics • Perform Medical Device Batch Release activities • Support execution of GMP audits and the supplier identification and selection process • Work collaboratively and take responsibility for deliverables

🎯 Requirements

• 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. • 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

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