Position Overview
We are seeking a Site Quality & Compliance Lead to support quality and compliance activities across clinical development programs. This role will drive inspection readiness, quality oversight, audit support, and training initiatives to ensure regulatory compliance and operational excellence.
Key Responsibilities
- Support GCP compliance, quality oversight, and inspection readiness activities.
- Manage audits, non-compliance issues, CAPAs, and quality reviews.
- Monitor quality metrics, identify risks, and support mitigation plans.
- Develop and deliver training and onboarding initiatives.
- Support process improvements and quality system activities.
- Partner with Clinical Operations, Quality, Regulatory, and other cross-functional teams.
Required Qualifications
- Bachelor's degree, preferably in Life Sciences or a related field.
- Experience in Clinical Quality, Clinical Operations, Quality Assurance, or clinical research.
- Knowledge of FDA, ICH-GCP, and clinical trial regulations.
- Experience with audits, CAPA management, compliance programs, and inspection readiness.
- Strong project management, communication, and stakeholder management skills.
Preferred Qualifications
- Experience supporting global clinical development programs.
- Experience developing training programs.
- Experience supporting regulatory inspections and internal audits.
#MSPTalent
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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].