Oversee the execution of high-quality GCP & IVDR Inspection Readiness & Preparation
Own the Site Inspection Readiness & Preparation project management for all clinical trials and programs covering early, late, and observational programs
Participate in developing and implementing innovative cross-functional Inspection Readiness (IR), Inspection Preparation, and Operational Quality (OQ) initiatives
Lead GCP & IVDR Regulatory Site Inspection Readiness and Preparation project management using tools, materials, apps and systems
Leading teams through smooth inspection experiences and successful inspection outcomes
Innovate continuous improvement in operational quality inspection readiness by identifying and acting on program, study and site quality incidents
Maintain and manage IR SharePoint (SPO) site
Providing mentorship to student interns

Bachelor Degree in Life Sciences or RN or equivalent
7 years work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
Experience of, or oversight of global clinical trial conduct
Experience driving and leading process development and /or improvement
Experience as an Inspection, or Risk Manager, preferred

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Inspection Readiness Manager

Key skills