Clinical Quality Specialist — GCP & CAPA (Hybrid, Waltham)

Groe Advisors LLC; Waltham (MA); Hybrid; USD 85.000 - 120.000; Vollzeit

Zusammenfassung

Groe Advisors LLC in the United States seeks a Clinical Quality Specialist to support quality operations across sponsor and CRO activities in line with ICH, GxP, and FDA requirements.

You will contribute to CAPA, deviations, quality investigations, audits, and vendor management, ensuring inspection readiness. Onsite presence in Waltham, MA is required 3–5 days weekly, with hybrid work flexibility.

Qualifikationen

• Strong GCP experience within clinical quality.
• Sponsor-side or CRO experience in clinical research/pharma.
• Hands-on CAPA, deviations, quality investigations, and issue resolution.
• Experience with audits, vendor management, and inspection readiness.
• Working knowledge of FDA regulations, ICH guidelines and GxP.

Aufgaben

• Support Clinical Quality and operations to ensure compliance of company clinical studies.
• Lead CAPA, deviation, and quality issue management.
• Oversee audits, vendor management, and inspection readiness.
• Work onsite in Waltham, MA, 3–5 days per week.
• Understand sponsor or CRO QA processes vs site/manufacturing environments.

Kenntnisse

GCP experience

Sponsor/CRO experience

CAPA & Deviations

Audits & Vendor mgmt

FDA/ICH/GxP knowledge

Tools

Veeva

TrackWise

Jobbeschreibung

Groe Advisors LLC in the United States seeks a Clinical Quality Specialist to support quality operations across sponsor and CRO activities in line with ICH, GxP, and FDA requirements.

You will contribute to CAPA, deviations, quality investigations, audits, and vendor management, ensuring inspection readiness. Onsite presence in Waltham, MA is required 3–5 days weekly, with hybrid work flexibility.