Senior Manager, Global Development Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee, recruit, and nurture direct reports by conducting monthly meetings and performance evaluations.

• Accountable for staff training, resource allocation, and individual professional development.

• Organize, prepare, execute, report on, and follow up regarding audits to support both routine and directed GxP audits.

• Serve as the department representative by offering audit and compliance insights during cross-functional meetings.

• Spearhead the detection of internal quality and compliance challenges, acting as a catalyst for process enhancements.

⛳️ Requirements

• Bachelor’s degree (Master’s degree preferred) with over 8 years of pertinent industry experience.

• Extensive knowledge of FDA and EU regulations, as well as ICH guidance documents.

• Preferred experience of 5+ years in direct people management and GCP audits.

• Familiarity with FDA or other Regulatory Inspections of Investigator sites, Sponsors, or CROs.

• Strong leadership abilities with a proven track record of collaboration with both direct reports and senior management.

• Excellent problem-solving skills along with proficient written and verbal communication abilities.

🏝️ Benefits

• Annual bonuses or other incentive programs.

• Equity awards.

• Pension or retirement plans.

• 401(k) company match.

• Health and wellness initiatives.

• Access to fitness centers.

• Comprehensive insurance benefits (e.g., medical, dental, vision, life, and disability).

• Paid time off.

• Family support benefits.