Senior Project Quality Assurance Lead

This is a fully remote position, open to applicants in Romania.

📋 Description

• Oversee QA activities and deliverables across various complex global studies and programs as assigned.

• Work collaboratively with project team members to ensure adherence to study protocols and regulations.

• Serve as a GCP Subject Matter Expert (SME), offering GCP consultancy to project teams for designated projects.

• Manage and facilitate investigations and root cause analyses for Quality Issues (QIs), including the development of Corrective and Preventive Action (CAPA) Plans for designated projects.

• Engage in risk management activities.

• Proactively identify risks to ensure that mitigations and controls are effectively implemented.

• Conduct quality assurance reviews and trending activities for assigned projects and programs.

• Provide GCP consultancy and evaluate QMD deviations for assigned projects and programs.

• Collaborate with Therapeutic Area Quality Leads within the Quality Management Oversight (QMO) team and assist in managing the QA-to-QA relationship with Sponsor QA counterparts and quality metrics.

• Support Sponsor audits and regulatory inspections as required.

⛳️ Requirements

• Bachelor’s degree or equivalent with a focus on biological, physical, health, pharmacy, or other related sciences, along with 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 environment.

• Strong working knowledge of Quality Management Systems, ICH Guidelines, FDA Code of Federal Regulations, European Directives and Regulations, and UK Statutory Instruments relevant to GCP.

• Knowledge of GxP (e.g., GLP, GMP, GPVP, GPP) in addition to advanced GCP knowledge is preferred.

• Domestic and international travel may be required (not exceeding 15%).

🏝️ Benefits

• Competitive salary

• Flexible working hours

• Professional development budget

• Home office setup allowance

• Global team events