Operations Quality Specialist

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🕒 vor 20 Tagen

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

⚙️ Operations

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ICON plc

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1990

💊 Pharmazie

🧬 Biotechnologie

⚕️ Krankenversicherung

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc ist ein globaler Anbieter klinischer, beratender und kommerzieller Dienstleistungen für verschiedene Bereiche der Gesundheits- und Pharmaindustrie. Das Unternehmen bietet ein breites Spektrum an klinischen Lösungen, darunter dezentralisierte klinische Studien, Lösungen zur kardialen Sicherheit, Frühphasen‑Labore sowie medizinische Bildgebung. Darüber hinaus stellt ICON Technologielösungen bereit, die die Arzneimittelentwicklung von den frühen Phasen bis nach der Markteinführung unterstützen. Die therapeutische Expertise umfasst Kardiologie, Onkologie, Innere Medizin und mehr, mit einem starken Fokus auf transformative Therapien wie Zell‑ und Gentherapien sowie Biosimilars. ICON ist als führende Auftragsforschungsorganisation (CRO) anerkannt, liefert regelmäßig Thought Leadership und trägt zu Branchenpublikationen und ‑veranstaltungen bei. Die Services sind darauf ausgerichtet, klinische Studien zu optimieren, Regulatory Intelligence bereitzustellen und mittels robuster Datenanalysen und patientenzentrierter Lösungen Real‑World Evidence zu generieren.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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.