Quality Associate I (2863-1)

Position Summary

The Quality Associate supports quality oversight activities across clinical research programs and operational processes. This role partners with cross-functional stakeholders to promote compliance with applicable regulations, quality standards, and internal procedures while supporting risk management, inspection readiness, auditing activities, and continuous improvement initiatives.

Key Responsibilities

• Provide quality oversight for multiple concurrent studies or programs from planning through reporting phases, promoting quality-focused best practices and compliance.
• Collaborate with cross-functional stakeholders and participate in project- and study-level meetings to support quality objectives.
• Affiliate in evaluating and tracking significant quality events, protocol deviations, compliance issues, data integrity concerns, and corrective actions, ensuring timely escalation and follow-up when appropriate.
• Support risk assessments and risk-based quality management activities, including the development and execution of annual audit plans.
• Contribute to the identification and assessment of audit needs for study sites, vendors, and service providers based on established risk criteria.
• Prepare and provide quality-related documentation and information to support internal and external audits.
• Participate in vendor risk assessments and contribute to vendor qualification, oversight, and audit planning activities.
• Review and support corrective and preventive action (CAPA) activities associated with audits, inspections, quality events, and documentation reviews.
• Participate in quality team meetings and contribute to ongoing quality initiatives and continuous improvement efforts.
• Maintain current knowledge of applicable regulations, guidelines, and quality standards through ongoing training and professional development.
• Support inspection readiness initiatives by assisting with training activities, mock interviews, readiness assessments, and response preparation.
• Participate in pharmacovigilance and quality system activities as assigned, including review of applicable documentation and compliance requirements.
• Affiliate with process improvement initiatives designed to strengthen quality systems and operational effectiveness.

Qualifications

• Bachelor's degree in Life Sciences or a related field.
• Training and/or certifications in quality-related disciplines such as Good Clinical Practice (GCP), Root Cause Analysis (RCA), or similar quality methodologies.
• Experience within the pharmaceutical, biotechnology, healthcare, research, or related regulated industries in quality assurance, compliance, clinical operations, regulatory affairs, or a similar function.
• Working knowledge of ICH GCP guidelines, regulatory requirements, and quality management principles.
• Strong analytical and problem-solving skills with the ability to identify trends and support root cause investigations.
• Excellent attention to detail and organizational skills.
• Strong written and verbal communication skills, including the ability to document findings clearly and communicate effectively across functional teams.
• Ability to work collaboratively in a cross-functional environment and manage multiple priorities simultaneously.
• Adaptability and willingness to learn new technologies, systems, and evolving quality processes.

Preferred

• Experience with quality management systems (QMS), including platforms such as TrackWise or equivalent systems.
• Experience supporting audits, inspections, CAPA management, risk assessments, or inspection readiness activities.
• Familiarity with pharmacovigilance, clinical research, and regulated quality environments.

Benefits

• Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.