Inspection Readiness Manager

Amgen • Thousand Oaks, CA

3d • $114,745 - $143,236 • Hybrid

About The Position

In this vital operational quality role, you will oversee the execution of high-quality GCP & IVDR Inspection Readiness & Preparation. You will own the Site Inspection Readiness & Preparation project management for all clinical trials and programs covering early, late, and observational programs. You will also participate in developing and implementing innovative cross-functional Inspection Readiness (IR), Inspection Preparation, and Operational Quality (OQ) initiatives, using curiosity, tenacity and a critical thinking mind. This role offers great scope for a high level understanding the drug development process, how Amgen is organized and the crucial role quality has in ensuring successful regulatory inspections and products reaching the market with speed and data integrity. As a growth area, creativity and engagement and drive are key characteristics of this role, alongside excellent communication.

Requirements

• 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

Nice To Haves

• Experience as an Inspection, or Risk Manager, preferred

Responsibilities

• Own and 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, trends and updating existing tools or creating new support materials, or workstreams.
• Lead, as appropriate, and collaborate with the IR Support Team on function specific GCP & IVDR IR, Study Health and Quality initiatives as indicated by operational observation, poor risk mitigation, quality data reports, inspection observations and findings, or specific country requirements e.g. China.
• Advisory role to the business in achieving Inspection Readiness Inspection, and a limited role in internal audits.
• Maintaining and managing IR SharePoint (SPO) site.
• Managing Regulatory Inspection Preparation folders and access.
• Supporting the Inspection Readiness & Operational Quality, Senior Manager.
• Provide mentorship to student interns.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior