Associate Director, Clinical Quality
Location
United States
Posted
8 days ago
Salary
Not specified
Seniority
Lead
No structured requirement data.
Job Description
Job Summary
The Associate Director, Clinical Quality is responsible for providing strategic and operational GCP quality oversight across assigned clinical programs. This role partners closely with clinical teams and stakeholders to ensure continuous inspection readiness, protect subject safety, and maintain data integrity throughout the clinical trial lifecycle. Acting as a trusted quality advisor, the position delivers expert guidance on global GCP regulations, drives risk‑based decision‑making, and proactively identifies and mitigates compliance risks. The role leads complex audits, supports health authority inspections, manages investigations into significant quality issues, and ensures timely and effective corrective actions, while fostering a strong culture of quality, accountability, and collaboration across the organization. Additional responsibilities include SOP writing and reviews, gap assessments, vendor oversight, training development, and mentoring less experienced QA team members. Education and Experience:
- At least 10 years of experience in pharma, biotech, or related healthcare industries
- Minimum 7 years in GCP Quality Assurance at a Sponsor or CRO
- Global study experience in Phase I-III clinical trials, late stage experience is a plus
- Therapeutic experience in rare cardiopulmonary diseases like pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) preferred
- In-depth knowledge of ICH GCP and global clinical trial regulations
- Experience working with Global Data Protection requirements and reporting
- Advanced vendor and clinical site auditing expertise, including translating findings into risk-mitigating action plans
- Excellent communication, technical writing, negotiation, and teamwork skills
- Strong analytical abilities, sound judgment, and effective project management under tight timelines
- Oversee quality assurance for Liquidia’s clinical study programs working across multiple business units, focusing on continuous inspection readiness and compliance
- Quality reviewer for study related documentation as applicable (e.g. Protocols, ICFs, Study Plans, etc.)
- Act as a strategic quality advisor, partnering with clinical teams and stakeholders to guide risk-based decisions in research quality
- Provide expert GCP compliance guidance, training, and recommendations to program teams and leadership
- Develop, implement, and manage risk-based audit strategies and conduct complex audits in line with GCP and Liquidia policies
- Assess and escalate compliance risks impacting subject safety, data integrity, or business operations to management
- Ensure completion of timely audit reports and corrective actions, tracking effectiveness and regulatory reporting as needed
- Manage and lead investigations into significant GCP quality issues, ensuring root cause analysis and effective corrective actions
- Monitor studies on assigned programs for global data protection compliance
- Support and manage GCP health authority inspections, guiding teams in preparation, response, and follow-up activities
- Collaborate with Quality teams to identify, analyze, and address GCP compliance issues and present key metrics and recommendations to management
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