Job Title: Quality Associate
Location: Remote
Job Summary: We are supporting a confidential search for a Quality Associate to help drive quality oversight across multiple ongoing studies from planning through reporting. Our team is seeking a detail-oriented professional who can collaborate cross-functionally, support inspection readiness, and contribute to quality processes that help protect study integrity and compliance.
Responsibilities:
- Provide quality oversight across multiple ongoing studies and support best practices throughout the study lifecycle.
- Collaborate with stakeholders and cross-functional teams to support meetings, quality discussions, and study-level coordination.
- Support risk assessments, audit planning, vendor assessment activities, and documentation preparation for audits and inspections.
- Contribute to CAPA reviews, controlled document harmonization, inspection readiness activities, and assigned PV-related tasks.
Required:
- Bachelor’s degree in life science or related quality training and/or certifications, such as Root Cause Analysis (RCA) or Good Clinical Practice (GCP).
- Experience in the pharmaceutical industry, biotech, or CRO environment with clinical quality assurance, GxP compliance, clinical trial operations, and/or regulatory affairs.
- Strong knowledge of ICH GCP, health authority regulations, and global clinical trial requirements.
- Strong attention to detail, data analysis ability, trend identification skills, and the ability to perform Root Cause Analysis.
- Ability to document findings clearly, communicate effectively across functional areas, and work collaboratively with quality and functional team members.
- Experience in TrackWise or a similar QMS platform is preferred.
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.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy