Associate Director, CQA

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, Clinical Quality Assurance (CQA) in the United States.

This role offers an exciting opportunity to lead and oversee clinical quality assurance operations within a dynamic pharmaceutical environment. You will provide GCP compliance oversight, support clinical study teams, and manage internal and external audits, ensuring adherence to domestic and international quality regulations. The role involves strategic contributions to inspection readiness, audit lifecycle management, and continuous improvement initiatives. You will collaborate with cross-functional teams, including clinical development, regulatory, and partner organizations, to ensure high-quality outcomes and regulatory compliance across clinical programs. This position is ideal for a proactive professional seeking impact in a fast-paced, global clinical operations environment.

• Accountabilities
• Provide GCP compliance support and guidance to clinical study teams across therapeutic areas.
• Lead audits of investigator sites, internal functional/process areas, and clinical vendors (GCP, GCLP, GPvP).
• Manage audit lifecycle activities, including planning, execution, reporting, CAPA issuance, and closure.
• Support inspection readiness and participate in regulatory inspections, collaborating with study teams, CROs, and partners.
• Monitor compliance trends, maintain audit records in electronic quality management systems, and present findings to relevant stakeholders.
• Identify, escalate, and address serious non-compliance issues, and ensure completion of corrective and preventative actions.
• Collaborate with internal and external quality counterparts, supporting strategic process improvement initiatives and ensuring business continuity.
• Requirements
• Bachelor’s degree in Biological or Life Sciences or a related discipline.
• 8+ years of experience in pharmaceutical drug development in Clinical Quality Assurance or GCP-related disciplines.
• Proven experience working with clinical study teams and leading audits of GCP/GCLP/GPvP vendors, investigator sites, and internal functional areas.
• Knowledge of ICH Guidelines and domestic and international GCP regulations.
• Experience managing inspection readiness and supporting FDA, EMA, and other health authority inspections.
• Strong interpersonal skills with the ability to build and maintain positive working relationships across departments.
• Self-motivated, highly organized, and able to manage multiple priorities under tight timelines.
• Excellent oral and written communication skills, with high professionalism and a customer-service orientation.
• Ability to work in standard office settings, operate office equipment, and perform occasional physical tasks such as lifting up to 25 pounds.
• Benefits
• Competitive base salary ($185,000–$200,000 annually) with performance-based bonus opportunities.
• Stock program participation.
• Comprehensive health, dental, and vision insurance.
• Paid time off and company holidays.
• Remote work flexibility or office-based options.
• Professional development opportunities and a collaborative work environment.

Why Apply Through Jobgether?

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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