Senior Manager, Global Development Quality Assurance (GCP)

Responsibilities

• Manage and develop direct reports through monthly meetings and performance assessments
• Conduct training and ensure proper resourcing for staff development
• Schedule and perform audits in support of GxP compliance
• Conduct internal and external audits on a global scale
• Provide compliance input in cross-functional meetings
• Identify internal quality/compliance issues and promote process improvements
• Provide education and/or training to GDQA and other relevant departments

Qualifications

• Bachelor's degree required, Master's preferred, with 8+ years of relevant industry experience
• Deep knowledge of FDA and EU regulations and ICH guidance documents
• 5+ years of direct people management and GCP audit experience
• Excellent communication skills for all organizational levels
• Experience with FDA regulatory inspections of investigator sites, sponsors, or CROs

Benefits

• Remote position based in the United States with required travel of 20-30%
• Potential for significant professional development and growth in a key leadership role
• Engagement in impactful quality assurance activities that influence drug development

Pay

$134,400 – $219,200 annually

Schedule

Required travel of 20-30%