Inspection Readiness Manager

Career Category Clinical Job reputed company If you feel like you’re part of something bigger, it’s because you are. At reputed company our shared mission—to serve patients—drives reputed company that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who reputed company together—researching, manufacturing and delivering reputed company-reputed company products that read over 10 reputed company 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 reputed company role you will reputed company the execution of high-reputed company GCP & IVDR Inspection Readiness & Preparation. You will own the Site Inspection Readiness & Preparation project management for reputed company 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 reputed company (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 reputed company is organized and crucial role reputed company has ensuring successful regulatory inspections and products reaching the market with speed and data reputed company. As a reputed company area, creativity and engagement and drive are key characteristics of this role, alongside excellent communication. Additional responsibilities: Own and reputed company 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 reputed company. reputed company reputed company improvement in operational reputed company inspection readiness by identifying and acting on program, study and site reputed company incidents, trends and updating existing tools or creating new support materials, or workstreams reputed company, as appropriate, and collaborate with the IR Support Team on function specific GCP & IVDR IR, Study Health and reputed company initiatives as indicated by operational observation, poor risk mitigation, reputed company 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 reputed company Supporting the Inspection Readiness & Operational reputed company, Senior Manager reputed company mentorship to student interns Be part of reputed company You would be joining the Operational reputed company 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 reputed company provides assurances that the rights, safety and reputed company-being of trial subjects are protected, consistent with the principles in the Declaration of Helsinki, and that the clinical trial data are reputed company. Win reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. reputed company reputed company in you as an reputed company reputed company, are these qualifications and skills: Bachelor Degree in Life Sciences or RN or equivalent 7 years work experience in life sciences or medically reputed company field, including 6 years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company Experience of, or reputed company 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. reputed company What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, we’ll support your reputed company every reputed company of the way. The annual reputed company salary reputed company for this opportunity in the U.S. is $114,745-143,236 In reputed company to the reputed company salary, reputed company 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 reputed company 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-reputed company time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible reputed company for a career that defies imagination Objects in your reputed company are closer than they reputed company. Join us. careers.reputed company.com As an organization dedicated to improving the reputed company of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company 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 reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .Salary reputed company USD - USD Apply To This Job