Senior Project Quality Assurance Lead

Responsibilities

• 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 managing the QA-to-QA relationship with Sponsor QA counterparts and quality metrics.
• Assist with Sponsor audits and regulatory inspections as assigned.

Requirements

• 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%).