Associate Director, GCP QA & Global Audit Oversight

Ascentage Pharma; United States; On-site; USD 140,000 - 210,000; Full time

Job summary

Ascentage Pharma seeks an experienced Associate Director, Quality Assurance (QA), GCP to provide strategic and operational quality oversight for Phase I-III global clinical development. This role ensures GCP compliance across sites, labs, CROs and vendors, driving inspection readiness and CAPA programs across North and South America.

The ideal candidate will lead QA partnerships with Clinical Operations and Regulatory Affairs, support regulatory inspections, and champion risk-based quality

Qualifications

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

Responsibilities

• Develop and execute risk-based GCP quality oversight programs for Phase I-III clinical trials.
• Conduct investigator site audits, for‑cause audits, and process audits across global clinical programs.
• Provide proactive oversight of high-enrolling, critical, and strategically important clinical sites.
• Evaluate site compliance with protocol requirements, GCP regulations, informed consent processes, data integrity, patient safety, investigational product accountability, and essential documentation.
• Collaborate with Clinical Operations and study teams to identify quality trends and emerging compliance risks.
• Support root cause investigations, CAPA development, effectiveness verification, and risk mitigation activities.
• Plan and conduct audits of central laboratories, specialty laboratories, bioanalytical laboratories, and sample management facilities.
• Assess laboratory compliance with applicable GCP, GLP, GCLP, and regulatory requirements.
• Ensure laboratory processes support data reliability, traceability, chain of custody, sample integrity, and patient safety.
• Evaluate laboratory quality systems and support remediation activities when required.
• Lead qualification, routine surveillance, and for‑cause audits of CROs, central service providers, technology vendors, imaging vendors, logistics providers, and other outsourced partners.
• Assess vendor quality systems and operational performance against applicable regulations and contractual obligations.
• Partner with Vendor Management and Clinical Operations to establish risk-based oversight strategies.
• Review vendor quality metrics, deviations, CAPAs, inspection histories, and performance indicators.
• Support vendor governance meetings and quality business reviews.
• Lead inspection readiness activities for high-enrolling, critical, and high-risk clinical sites across global studies.
• Support preparation for FDA, EMA, MHRA, PMDA, NMPA, and other global health authority inspections.
• Conduct mock inspections, inspection simulations, and quality gap assessments.
• Participate in inspection war rooms and provide expert QA support during regulatory inspections.
• Review inspection responses, commitments, remediation plans, and CAPA implementation activities.
• Partner with study teams to maintain a continuous state of inspection readiness throughout the clinical trial lifecycle.
• Support implementation and continuous improvement of global GCP quality systems.
• Review and trend audit findings, quality events, protocol deviations, vendor issues, and compliance metrics.
• Contribute to development and revision of SOPs, work instructions, guidance documents, and training materials.
• Promote Quality‑by‑Design and risk‑based quality management principles across clinical development programs.
• Identify systemic quality risks and recommend sustainable corrective and preventive actions.
• Serve as a trusted QA advisor to clinical development leadership and cross‑functional teams.
• Influence quality strategy and risk management decisions for global clinical programs.
• Mentor junior QA professionals and contribute to organizational capability development.
• Represent Quality Assurance on study teams, governance committees, and vendor oversight forums.
• Support regulatory intelligence and implementation of evolving global GCP requirements.
• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biology, Chemistry, or related discipline required.

Skills

Quality oversight

Audit programs

Inspection readiness

GCP regulations

Regulatory inspections

Risk-based QA

Cross-functional leadership

Data integrity

Vendor/auditor oversight

Travel readiness

Education

Bachelor's degree in Life Sciences/Pharmacy/Biology/Chemistry

Advanced degree preferred

Certifications such as CQA/RQAP-GCP desirable

Job description

Ascentage Pharma seeks an experienced Associate Director, Quality Assurance (QA), GCP to provide strategic and operational quality oversight for Phase I-III global clinical development. This role ensures GCP compliance across sites, labs, CROs and vendors, driving inspection readiness and CAPA programs across North and South America.

The ideal candidate will lead QA partnerships with Clinical Operations and Regulatory Affairs, support regulatory inspections, and champion risk-based quality