Clinical Quality & Compliance Specialist

Talent Groups; Waltham (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Talent Groups is seeking a Clinical Quality Operations professional in Massachusetts to support audits, inspection readiness, deviations, and change controls.

The ideal candidate has a life sciences degree and 3–6 years of pharmaceutical, biotech, or CRO clinical quality experience, plus knowledge of ICH-GCP, GxP, FDA, and EMA. Experience with Veeva, TrackWise, or ComplianceWire is a plus and familiarity with Microsoft Copilot is a bonus.

Qualifications

• 3–6 years of experience in pharmaceutical, biotech, or CRO clinical quality.
• Knowledge of ICH-GCP, GxP, FDA, and EMA requirements.
• Experience with Veeva, TrackWise, or ComplianceWire is a plus.

Responsibilities

• Support clinical quality operations, audits, and inspection readiness.
• Coordinate audit schedules and follow up on findings.
• Assist with deviations, quality investigations, and change controls.
• Maintain Clinical Quality Vendor Management records.
• Track quality metrics and support reporting.
• Help with training management and onboarding activities.

Skills

Clinical quality experience

Education

Bachelor's degree in Life Sciences, Quality, Pharmacy, or related field

Tools

Veeva

TrackWise

ComplianceWire

Microsoft Copilot

Job description

Talent Groups is seeking a Clinical Quality Operations professional in Massachusetts to support audits, inspection readiness, deviations, and change controls.

The ideal candidate has a life sciences degree and 3–6 years of pharmaceutical, biotech, or CRO clinical quality experience, plus knowledge of ICH-GCP, GxP, FDA, and EMA. Experience with Veeva, TrackWise, or ComplianceWire is a plus and familiarity with Microsoft Copilot is a bonus.