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ICON plc logo
ICON plc

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients, and suppliers.

Operations Quality Specialist

OperationsOperationsFull TimeRemoteSeniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

Pennsylvania

Posted

37 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Operations Quality Specialist

ICON plc

• Support overall quality within assigned clinical trials and submissions • For assigned clinical trials or assets, is point of contact for operational related quality consultation, escalating to QA as needed • Provide risk-management, consultation, assessment, and recommendations for escalation for potential quality issues or trends • Provide training and coaching to promote awareness educating study teams towards quality deliverables • Support teams in adherence to GCP and procedural documents and processes to ensure quality deliverables • Work with teams to escalate quality issues with CROs to QA, supporting teams to bring CROs into compliance; and looks for opportunity to collaborate with other members of QuIP to trend across Strategic Partnership(s) to communicate to QA. • Work with Study Team leadership (and QA, as needed) to identify quality issues and plan of action, including support for creation of deviations and development of effective CAPA and Storyboards • Support inspection readiness activities with the Study CTM/Sr. CTM, Asset Lead, QA Representative, and QuIP Director or designee • Plan and lead Study Team inspection readiness support meetings based on QA’s plan and Study Team’s needs • Support QA in their inspection readiness team meetings and collaborate with QA for information needed and requested for any inspections • Assists with stakeholder engagement across program to ensure compliance with inspection readiness and preparation activities • Support teams in preparation, execution, and follow-up of regulatory inspections • Review critical/major findings with QA Audit reports to propose process improvement • Provide consult on KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality

Job Requirements

  • Bachelor’s degree or equivalent with a strong emphasis on science or quality management
  • Minimum of 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent
  • Minimum of 3 years’ experience in quality role
  • Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience
  • Ability to travel

Benefits

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize 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.

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