Clinical Quality Operations Specialist

Green Key Resources; Waltham (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Green Key Resources is seeking a Clinical Quality Specialist to support Clinical Quality Operations and ensure compliance with US FDA and European regulations, ICH, and GxP standards. The role is under the direction of the CQA management team, focusing on regulatory readiness and vendor management.

Responsibilities include coordinating audits, assisting in deviations and investigations, generating metrics, and participating in governance meetings.

Qualifications

• Bachelor’s degree or higher in relevant computer, technical, quality, scientific discipline.
• Minimum of 3–6 years of experience in commercial pharma, CRO, clinical pharma, or healthcare facility.
• Proficient in MS Word, Excel, and Quality System processes. Experience with Veeva, TrackWise, and ComplianceWire is a plus.
• Understanding and working knowledge of US FDA and European regulatory requirements. Knowledge of Regulatory Compliance, ICH Guidelines, GxP standards.

Responsibilities

• Support auditing processes and audit plans.
• Coordinate investigations, escalation and resolution of issues.
• Assist in scheduling audits with stakeholders.
• Collect and generate metrics for Clinical Quality Operations.
• Participate in meetings/workshops with Site Process Owners and SMEs.
• Assist in deviations, quality investigations and audits.
• Support vendor management database maintenance.

Skills

Quality system processes

MS Word

Excel

Education

Bachelor’s degree or higher in relevant field

Tools

Veeva

TrackWise

ComplianceWire

Job description

Green Key Resources is seeking a Clinical Quality Specialist to support Clinical Quality Operations and ensure compliance with US FDA and European regulations, ICH, and GxP standards. The role is under the direction of the CQA management team, focusing on regulatory readiness and vendor management.

Responsibilities include coordinating audits, assisting in deviations and investigations, generating metrics, and participating in governance meetings.