Inspection Readiness Manager
Career Category Clinical
Job Description
If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. Inspection Readiness Manager LIVE What you will do 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 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. Additional 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 Be part of our team You would be joining the Operational Quality team who serve patients by providing inspection readiness, trial master file and clinical trial risk management support primarily to Clinical Program Operations, to ensure adherence to ICH GCP. Compliance with this standard provides assurances that the rights, safety and well-being of trial subjects are protected, consistent with the principles in the Declaration of Helsinki, and that the clinical trial data are credible. Win 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: 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 We encourage applicants to submit their CV along with a cover letter for consideration. Thrive What you can expect of 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 annual base salary range for this opportunity in the U.S. is $114,745-143,236 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: 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 Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .Salary Range USD - USD Apply To This Job