Quality Associate I (2863-1)

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.

• 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.
• Assist 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.
• Support quality governance activities, including collaboration with internal teams and external partners.
• Review and assist with the development, harmonization, and maintenance of controlled documents, such as protocols, informed consent forms, study reports, amendments, procedures, and templates.
• 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.
• Assist with process improvement initiatives designed to strengthen quality systems and operational effectiveness.

Required

• 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.

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

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.