Inspection Readiness Manager

Inspection Readiness Manager

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What You Will Do

Let's do this. Let's change the world. In this vital global 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 crucial role quality has 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.

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

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills :

Basic Qualifications :

Preferred Qualifications :

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities that may include :

Apply now and make a lasting impact with the Amgen team.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.