Quality Associate

Job Title: Quality Associate II

Location: Remote (EST OR CST candidates only) Job Summary: We are seeking a Quality Associate II to support end-to-end clinical study quality oversight, from protocol development through study closeout and reporting. This opportunity is ideal for a quality professional who can partner across clinical, data, biostatistics, and operational teams to strengthen compliance, manage risk, and drive continuous improvement.

Responsibilities

• Provide quality oversight across multiple ongoing clinical studies and support study execution from development through closeout.
• Review quality metrics, operational data, and performance trends to identify risks, compliance concerns, and opportunities for improvement.
• Evaluate quality issues, protocol deviations, data integrity concerns, significant noncompliance events, and potential Serious Breaches, escalating findings as appropriate.
• Support CAPA follow-up, risk assessments, audit planning, vendor oversight, inspection readiness, and continuous improvement activities.

Required:

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, Biostatistics, Clinical Research, or a related scientific discipline.
• Minimum 4+ years of experience in the pharmaceutical, biotechnology, medical device, or CRO industry.
• Strong hands-on GCP experience is the highest priority.
• Broad understanding of the end-to-end clinical trial/development process.
• Experience across Phase I–III studies is preferred
• Clinical Operations and/or Data Management familiarity is valuable.
• Experience working with CROs/vendors.
• GCP auditing experience is relevant.

About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.

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