Senior Project Quality Assurance Lead

Worldwide Clinical Trials

Senior Project Quality Assurance Lead managing QA activities across global studies for clinical trials. Enhancing compliance and quality management in a clinical research organization environment.

Posted 5/28/2026full-timeRemote • 🇷🇴 RomaniaSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead QA activities and deliverables across multiple complex and global studies and programs as assigned.
Collaborates with project team members to ensure compliance with study protocols and regulations.
Acts as GCP Subject Matter Expert (SME) providing GCP consultancy to project teams for assigned projects.
Manages and facilitates investigation and root cause analysis for Quality Issues (QIs) including development of Corrective and Preventive Action (CAPA) Plans for assigned projects.
Participates in risk management activities.
Proactive identification of risks to ensure mitigations and controls are in place.
Performs quality assurance review and trending activities for assigned projects and programs.
Provides GCP consultancy and reviews QMD deviations for assigned projects and programs.
Collaborates with the Therapeutic Area Quality Lead(s) within the Quality Management Oversight (QMO) team and supports with managing the QA-to-QA relationship with Sponsor QA counterparts and quality metrics.
Assist with Sponsor audits and regulatory inspections as assigned.

Requirements

What you’ll need

Bachelor’s degree or equivalent with concentration in biological, physical, health, pharmacy or other related science and 7+ years of relevant GCP experience OR 5+ years of relevant GCP experience with a M.S. or equivalent in a scientific or allied health field preferably within a Clinical Research Organization (CRO) or pharmaceutical company setting.
Excellent working knowledge of Quality Management Systems, ICH Guidelines, FDA Code of Federal regulations, European Directives and Regulations, and UK Statutory Instruments relevant to GCP.
GxP (e.g., GLP, GMP, GPVP, GPP) knowledge in addition to advanced GCP knowledge preferred.
Domestic and international travel may be required (not exceeding 15%).

Benefits

Comp & perks

Competitive salary
Flexible working hours
Professional development budget
Home office setup allowance
Global team events

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GCPQuality Management SystemsCorrective and Preventive Action (CAPA)risk managementquality assurance reviewroot cause analysisQMD deviationsGxPICH GuidelinesFDA Code of Federal Regulations

Soft Skills

collaborationcommunicationproactive identification of risksfacilitationproblem-solving