About this role

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.

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.

Senior Manager, Global Development Quality Assurance

Key skills