Senior Manager, Global Development Quality Assurance

QA EngineerQA EngineerFull TimeRemoteSeniorTeam 10,001+Since 1988H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

5 days ago

Salary

$134.4K - $219.2K / year

Seniority

Senior

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

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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