Quality Associate II

About the role

Our client, a life sciences organization, has engaged GForce Life Sciences to provide a Quality Associate II. This position will support quality oversight across multiple ongoing clinical studies, from protocol development through study closeout and reporting.

Responsibilities

• Provide quality oversight for clinical studies, including review of study quality metrics, operational data, and performance trends.
• Identify emerging risks, compliance issues, and opportunities for process improvement in clinical trial activities.
• Collaborate with cross-functional stakeholders to ensure quality considerations are integrated into study design, protocol development, risk management, and study execution plans.
• Evaluate quality issues such as protocol deviations, data integrity concerns, significant non-compliance events, and potential Serious Breaches, escalating findings as appropriate.
• Conduct follow-up and effectiveness reviews of CAPAs, audit findings, and inspection observations.
• Support risk assessments and quality management activities for vendors and service providers in clinical studies.
• Review and assess quality documentation including protocols, informed consent forms, amendments, CSR, quality records, and procedural documents.
• Perform trend analysis of quality metrics and compliance data to identify systemic issues and recommend mitigation strategies.
• Support inspection readiness initiatives across Sponsor, CRO, and investigational sites.
• Participate in audit planning, audit prioritization, and quality governance forums.
• Review quality and safety documentation such as PSMFs and support PV quality activities as assigned.
• Mentor junior quality professionals and assist with onboarding and training efforts.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, Biostatistics, Clinical Research, or a related scientific discipline.
• Minimum of 4 years of experience supporting clinical trials within the pharmaceutical, biotech, medical device, or CRO industry.
• Experience supporting clinical trial design, oversight, and reporting across one or more development phases.
• Demonstrated ability to analyze clinical and operational data, identify trends, and recommend quality improvements.
• Strong knowledge of ICH-GCP guidelines, FDA regulations, EMA requirements, and global clinical research regulations.
• Experience conducting quality reviews, root cause analyses, CAPA assessments, and compliance risk evaluations.
• Excellent written and verbal communication skills, with strong organizational skills to manage multiple priorities.
• Proficiency with Microsoft Office and data analysis/reporting tools.
• Ability to work independently and exercise sound judgment regarding quality and compliance.

Skills

• GCP RCA, GxP quality management, Lean Six Sigma, ASQ or similar certifications (nice to have).
• Experience with Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM).
• Familiarity with electronic Quality Management Systems such as TrackWise.
• Knowledge of clinical data management, biostatistics, and clinical analytics concepts.
• Experience supporting global multicenter trials and CRO oversight activities.