Associate Director, Clinical QA — GCP Compliance & Audits

ADARx Pharmaceuticals, Inc.; San Diego (CA); On-site; USD 175,000 - 195,000; Full time

Benefits offered by this job

Equity compensation

Performance bonuses

401(k) match

Flexible Spending Account

Life Insurance

Employee Assistance Program

Employee discounts

Paid vacation

Paid holidays

Paid sick leave

Job summary

ADARx Pharmaceuticals, Inc. is seeking an Associate Director of Clinical Quality Assurance to lead GCP compliance across all clinical programs. You will build a risk-based quality framework and partner with cross-functional teams to ensure readiness for regulatory submissions and inspections.

You will oversee audits of CROs and vendors, review INDs and NDA-related materials, and drive CAPA and training programs to embed quality throughout development.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree preferred.
• 10+ years of progressive GCP Quality Assurance experience in biotech/pharma.
• Direct experience supporting late-stage clinical trials (Phase 2/3) and NDA/MAA submissions with inspection readiness.
• Expert knowledge of global GCP regulations and guidance, including 21 CFR Parts 11, 50, 54, 56, 312; EU CTR; ICH E6(R2/R3), E8; GDPR; GCLP.
• Extensive experience leading GCP audits and managing regulatory inspections.
• Strategic and hands-on in a small, fast-paced biotech environment.
• Excellent communication, collaboration, and influencing skills across cross-functional teams.

Responsibilities

• Develop and execute the Clinical QA strategy aligned with goals.
• Implement risk-based QA systems, processes, SOPs, and policies for trials and submissions.
• Provide ongoing GCP quality oversight across programs.
• Partner with Clinical Ops, Regulatory, Data Management, and others to mitigate compliance risks.
• Oversee QA for CROs, labs, and vendors; ensure qualification and monitoring.
• Review key regulatory documents (INDs, protocols, IBs, NDAs, submissions).
• Lead planning and execution of a risk-based GCP audit program (sites, CROs, vendors).
• Oversee CAPA investigations and root-cause analysis with proper documentation.
• Lead inspection readiness activities for late-phase programs and regulatory inspections.
• Support NDA/BLA/MAA submission activities from a quality perspective.
• Develop and deliver annual GCP training programs and updates to stakeholders.

Skills

GCP Quality Assurance

Regulatory inspections

Quality systems

Leadership

Communication

Education

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Job description

ADARx Pharmaceuticals, Inc. is seeking an Associate Director of Clinical Quality Assurance to lead GCP compliance across all clinical programs. You will build a risk-based quality framework and partner with cross-functional teams to ensure readiness for regulatory submissions and inspections.

You will oversee audits of CROs and vendors, review INDs and NDA-related materials, and drive CAPA and training programs to embed quality throughout development.