Quality Specialist CQA

Groe Advisors LLC; Waltham (MA); Hybrid; USD 85,000 - 120,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

GCP experience

Sponsor/CRO experience

CAPA & Deviations

Audits & Vendor mgmt

FDA/ICH/GxP knowledge

Tools

Veeva

TrackWise

Job description

The Clinical Quality Specialist, under the direction of the CQA management team, will be responsible to support Clinical Quality and their operations in ensuring compliance of company clinical studies, vendor management, and inspection readiness according to approved procedures, global regulations and ICH, GxP requirements.

• Strong GCP experience within clinical quality.
• Sponsor-side or CRO experience in the clinical research/pharmaceutical industry.
• Hands-on experience supporting CAPAs, deviations, quality investigations, and issue resolution within a clinical quality environment.
• Experience with clinical quality assurance (CQA), audits, vendor management, and inspection readiness.
• Experience with quality systems such as Veeva and TrackWise, along with a working knowledge of FDA regulations, ICH guidelines, and GxP requirements.
• A willingness to work onsite in Waltham, MA, 3–5 days per week.

Please note: We specifically need candidates who understand clinical quality processes from the sponsor or CRO perspective, as the CAPA, deviation, and quality issue management processes differ significantly from those in site-based or manufacturing environments

Location: Hybrid, 3-5 days/week onsite in Waltham, MA.