Quality Associate II

GForce Life Sciences; Princeton (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

GForce Life Sciences seeks a Quality Associate II to support quality oversight across multiple clinical studies from protocol development through closeout and reporting.

The role involves reviewing quality metrics, identifying risks, and collaborating with cross-functional teams to ensure quality is integrated into study design, risk management, and execution plans. Requires 4+ years in clinical trials and strong knowledge of ICH-GCP and FDA/EMA regulations.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, Biostatistics, Clinical Research, or related field.
• Minimum of 4 years supporting clinical trials in pharma, biotech, medical device, or CRO.
• Experience with clinical trial design, oversight, and reporting across development phases.
• Ability to analyze clinical and operational data to identify trends and quality improvements.
• Strong knowledge of ICH-GCP, FDA, EMA, and global regulations.
• Experience conducting quality reviews, CAPA assessments, and risk evaluations.
• Excellent written and verbal communication with strong organization.

Responsibilities

• Provide quality oversight for clinical studies across protocol development to closeout.
• Identify risks, compliance issues, and opportunities for process improvements.
• Collaborate with cross-functional stakeholders to integrate quality into study design and execution.
• Evaluate protocol deviations, data integrity issues, and non-compliance events.
• Follow-up on CAPAs, audit findings, and inspection observations.
• Support risk assessments and quality management for vendors in studies.
• Review quality documentation including protocols, consent forms, amendments, CSR, and records.
• Perform trend analysis of quality metrics to identify systemic issues and mitigation strategies.
• Support inspection readiness across Sponsor, CRO, and investigational sites.
• Participate in audit planning, prioritization, and governance forums.
• Mentor junior quality professionals and assist with onboarding.

Skills

Data analysis

Communication

Independent judgment

Quality oversight

Education

Bachelor’s degree in Life Sciences or related

Tools

Microsoft Office

TrackWise

Data analysis tools

Job description

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.

DUTIES / EXPECTATIONS OF ROLE

• 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.

Mandatory 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.

NICE TO HAVE

• GCP RCA, GxP quality management, Lean Six Sigma, ASQ or similar certifications.
• 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.