Associate Director - Clinical Quality Assurance - CEDENT

The Clinical QA Associate Director is responsible for overseeing quality assurance activities related to clinical trials, ensuring compliance with regulatory standards, company policies, and industry best practices. This role includes strategic planning for quality improvement, managing critical quality issues, and supporting risk mitigation in clinical trial activities. The Associate Director will work closely with cross-functional teams to uphold a compliant culture and maintain high standards in clinical research.
 

• Support Clinical Quality Assurance (CQA) initiatives, including TMF and site audits.

• Collaborate with clinical teams to ensure compliance with GCP regulations and internal standards in clinical trial activities.

• Lead quality oversight in clinical program design and execution, including protocols, informed consent forms, CAPAs, and CSRs.

• Provide QA oversight for clinical trial partners, such as CROs and contractors, and manage onboarding for new third-party partners as needed.

• Oversee qualification and monitoring of GxP suppliers, escalating relevant findings to Quality Management and stakeholders.

• Review clinical agreements to define responsibilities and communication for quality-related activities.

• Conduct internal and external audits, including investigation follow-up, root cause analysis, corrective/preventive actions, and effectiveness checks.

• Develop strategic quality plans to support department growth and lead the clinical operations team in implementing GCP systems and procedures.
   

• BS/MS in science with 8+ years of pharmaceutical industry experience or equivalent.

• Knowledge of Quality/Compliance and GCP, GLP, and/or GMP requirements.

• Extensive experience in Clinical QA with strong organizational, detail-oriented, and communication skills.

• Ability to work independently in a collaborative environment; self-motivated.

• Experience with regulatory interactions, including FDA, EMA, and other global health authorities.

• Willingness to travel 10-20%.

• Experience fostering a GxP culture in a start-up environment is preferred.