Hybrid Clinical Quality Specialist (CQA)

Planet Pharma; Waltham (MA); Hybrid; USD 55,000 - 69,000; Full time

Job summary

Planet Pharma seeks a Clinical Quality Specialist, CQA, in Waltham, MA to support clinical quality operations, vendor management, and inspection readiness under CQA leadership. The position requires familiarity with FDA/ICH/GxP, and experience with QA systems and audits.

The role involves coordinating audits, managing deviation investigations, and contributing to training and onboarding of new staff. Hybrid work model offered; compensation details available on request.

Qualifications

• Bachelor’s degree or higher in a relevant computer, technical, quality, scientific discipline.
• 3–6 years of experience in commercial pharma, CRO, clinical pharma, or healthcare facility.
• Proficient in MS Word and Excel; familiarity with Quality System processes.

Responsibilities

• Support processing of audit reports, change controls, deviations, and audit plans.
• Coordinate, investigate, escalate, and resolve issues in Clinical Quality Operations.
• Schedule audits with internal and external stakeholders.
• Collect and generate metrics for Clinical Quality Operations.
• Participate in meetings with Site Process Owners and business SMEs.

Skills

MS Word

MS Excel

Quality System

Regulatory Understanding

Education

Bachelor’s degree or higher in relevant field

Tools

Veeva

TrackWise

ComplianceWire

Job description

Planet Pharma seeks a Clinical Quality Specialist, CQA, in Waltham, MA to support clinical quality operations, vendor management, and inspection readiness under CQA leadership. The position requires familiarity with FDA/ICH/GxP, and experience with QA systems and audits.

The role involves coordinating audits, managing deviation investigations, and contributing to training and onboarding of new staff. Hybrid work model offered; compensation details available on request.