Associate Director, QA & GCP Inspection Lead

Ascentage Pharma; United States; On-site; USD 170,000 - 210,000; Full time

Job summary

Ascentage Pharma is seeking an experienced Associate Director, QA for GCP Clinical Site, Laboratory & Vendor Oversight in North America and South America. You will partner with Clinical Operations, Medical Affairs, and external vendors to ensure compliance with ICH-GCP and global regulations across Phase I–III programs.

You will lead inspection readiness activities, manage risk-based QA programs, perform site and CRO audits, and mentor QA staff while supporting regulatory inspections.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biology, Chemistry, or related discipline.
• Advanced degree (MS, PharmD, PhD, MPH, or equivalent) preferred.
• Professional certifications such as CQA, RQAP-GCP, or equivalent desirable.

Responsibilities

• Lead GCP QA oversight for Phase I-III global clinical trials.
• Conduct investigator site audits, for-cause audits, and process audits across global clinical programs.
• Provide proactive oversight of high-enrolling, critical clinical sites.
• Evaluate site compliance with protocol requirements, GCP regulations, informed consent processes, data integrity, patient safety, and essential documentation.
• Collaborate with Clinical Operations to identify quality trends and emerging risks.
• Support root cause investigations, CAPA development, and risk mitigation activities.
• Plan and conduct audits of central and specialty laboratories and CROs.
• Lead inspection readiness activities for FDA/EMA etc. inspections.

Skills

QA Oversight

GCP Compliance

Auditing

Regulatory Inspection Readiness

Risk-Based Quality Management

Education

Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biology, Chemistry, or related discipline

Advanced degree (MS, PharmD, PhD, MPH, or equivalent) preferred

CQA or RQAP-GCP certification desirable

Job description

Ascentage Pharma is seeking an experienced Associate Director, QA for GCP Clinical Site, Laboratory & Vendor Oversight in North America and South America. You will partner with Clinical Operations, Medical Affairs, and external vendors to ensure compliance with ICH-GCP and global regulations across Phase I–III programs.

You will lead inspection readiness activities, manage risk-based QA programs, perform site and CRO audits, and mentor QA staff while supporting regulatory inspections.