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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.

Global Operations Quality Manager

OperationsOperationsOtherRemoteSeniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

Pennsylvania

Posted

90 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGCP

Job Description

Global Operations Quality Manager

ICON plc

• Provide quality consultation within assigned scope, escalating complex or enterprise-impacting issues to the Senior Global Quality Manager and/or Global Head - GCP Excellence, as appropriate • Lead issue assessments, root cause evaluation, and recommendations for QA escalation • Lead cross-study quality initiatives to define best practices, enhance quality maturity, and strengthen proactive risk identification • Support teams in interpreting and applying ICH GCP, regulatory expectations, procedural documents, and governance frameworks • Provide direction for deviation management, CAPA development, and quality-related storyboards • Promote a culture of quality, continuous improvement, and operational excellence that engages colleagues in positive dialogue consulting and supporting in all we do • Develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, as assigned • Contribute to the enhancement or creation of SOPs, WIs, guidance documents, and process optimization initiatives. • May drive continuous improvement projects aimed at strengthening quality culture, efficiency, and inspection readiness maturity • Provide training or awareness for new or established processes or guidance provided by QuIP • Collaborate in developing and presenting QuIP content for distribution within the organization • Author relevant content for the QuIP SharePoint sites • May act as lead on specified QuIP workstreams or assigned QuIP initiatives • Provide consultation and support for ad hoc requests that are sent to QuIP • Consult, develop, or identify opportunities for continuous improvement projects • Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials • Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus • Support overall quality within assigned clinical trials and submissions • 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, support teams to bring CROs into compliance; and look for opportunities to collaborate with other members of QuIP to trend across Strategic Partnership(s) to communicate to QA. • Support inspection readiness, preparation and conduct activities with the Study CTM/Sr. CTM, Asset Lead, QA Representative, and QuIP Leadership or designee as requested by the QuIP Inspection Excellence team. • Review critical/major findings with QA Audit reports to propose process improvement • Provide consultation 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
  • 5+ years’ experience in quality roles
  • Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience
  • Demonstrated experience with audits, inspections, and complex escalation management.

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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