Quality Assurance Manager
The Quality Assurance Manager oversees compliance and quality systems within clinical research operations. This role ensures trials adhere to regulatory requirements, SOPs, and Good Clinical Practice (GCP) standards, while driving continuous improvement across processes.
Responsibilities:
Develop, implement, and maintain quality management systems
Conduct audits of clinical sites, vendors, and internal processes
Ensure compliance with GCP, FDA, and ICH guidelines
Manage CAPAs, deviations, and risk assessments
Provide training and guidance on quality standards
Support inspection readiness and regulatory submissions
Skills & Experience:
Bachelor’s degree in life sciences or related field
Strong experience in clinical QA and regulatory compliance
Knowledge of GCP, FDA, ICH, and industry standards
Excellent analytical, communication, and leadership skills
EEO Employer
We are an equal opportunity employer and comply with all applicable federal, state, and local fair employment practices laws. We strictly prohibit and do not tolerate discrimination against employees, applicants, or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex, sexual orientation, gender (including gender identity and expression), marital or familial status, age, physical or mental disability, perceived disability, citizenship status, service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law. Applications from members of minority groups and women are encouraged.