Quality Manager II

Position Overview

We are seeking a Quality Manager II to support Clinical Quality and GCP compliance activities across clinical development programs. This role will support audit management, CAPA oversight, inspection readiness, and quality systems initiatives.

Key Responsibilities

  • Support GCP audits, inspection readiness, and quality assurance activities.
  • Coordinate audit documentation, reports, and follow-up actions.
  • Track CAPAs, quality issues, and compliance commitments.
  • Maintain quality records and quality management systems.
  • Prepare quality metrics, dashboards, and management reports.
  • Support cross-functional quality and process improvement initiatives.

Required Qualifications

  • Bachelor's degree in Life Sciences or a related field preferred.
  • 5+ years of experience in Clinical Quality, Quality Assurance, clinical research, biotechnology, or pharmaceutical environments.
  • Experience supporting GCP compliance, audits, CAPA management, and inspection readiness.
  • Knowledge of ICH-GCP and clinical development processes.
  • Experience with quality management systems and quality reporting.
  • Strong organizational, analytical, and communication skills.

Preferred Qualifications

  • Experience supporting regulatory inspections and audit programs.
  • Experience with Pharmacovigilance or GVP activities.
  • Experience with quality metrics, dashboards, and reporting.

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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 [email protected].