Senior Manager, Clinical Quality Assurance

📋 Description

• Provide GCP compliance oversight and quality guidance to clinical study teams, participating in
• Identify, assess, and escalate serious compliance issues, including potential serious breaches, to
• Maintain knowledge of global GCP regulations, ICH guidelines, internal policies, and procedures
• Act as a Clinical Quality Assurance point of contact for designated clinical areas and support
• Support study deviations, quality events, and CAPAs within GCP and pharmacovigilance.
• Collaborate with CRO quality counterparts and participate in quality oversight activities.

🎯 Requirements

• Bachelor’s degree in biological or life sciences (or related field) required.
• At least 6 years in pharmaceutical drug development with substantial QA/GCP experience.
• Strong knowledge of ICH guidelines and GCP regulations.
• Experience leading GCP/GCLP/GPvP audits of vendors/sites/functions.
• Experience with inspection readiness and inspections by FDA, EMA, and health authorities.
• Quality Auditor/Quality Manager certification preferred.

🎁 Benefits

• Annual salary range of $165,000–$180,000 USD, depending on qualifications and market factors.
• Stock program participation and performance-based bonus.
• Comprehensive benefits package.
• Supportive environment focused on clinical quality and regulatory compliance.
• Position may be remote within the United States.