Clinical Quality 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

• 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.

What We're Looking For:

• Bachelor's degree in Life Sciences, Quality, Pharmacy, or a related field.
• 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.
• Familiarity with Microsoft Copilot is a plus.