Senior Manager, Global Development Quality Assurance
Location
United States
Posted
5 days ago
Salary
$134.4K - $219.2K / year
Seniority
Senior
Job Description
Senior Manager, Global Development Quality Assurance
Regeneron
• Manage, hire and develop direct reports by meeting with direct reports at least monthly and conducting performance assessments. • Responsible for the training, resourcing, and individual staff development. • Schedule, prepare, conduct, report, and follow-up on audits in support of routine and directed GxP audits. • Represent the department by providing audit and compliance input in cross functional meetings. • Lead the identification of internal quality/compliance issues and act as a catalyst for process improvements.
Job Requirements
- Bachelor’s degree (Master’s degree preferred) with 8+ years of relevant industry experience
- Deep knowledge of the FDA and EU regulations and ICH guidance documents
- 5+ years of both direct people management and GCP audit experience preferred
- Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs
- Strong leadership with demonstrated ability to collaborate with both direct reports and senior leaders
- Good problem solving, written and verbal communication skills.
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
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