R&D QUALITY SENIOR MANAGER
Join our team at Amgen Capability Center Portugal, a leading workplace recognized by the Great Place to Work Institute. With over 400 talented individuals from more than 40 nationalities, our Lisbon center thrives at the intersection of innovation, excellence, and inspiration. This is your opportunity to explore the future of healthcare through technology and digital innovation, supporting our mission "To Serve Patients."
What You Will Do
In this vital role the R&D Quality Senior Manager will play a crucial part in ensuring global compliance with regulatory standards by preparing and coordinating cross‑functional teams for Regulatory Health Authority inspections. Responsibilities include developing and executing inspection management plans, managing and enhancing the R&D inspection framework, ensuring appropriate resourcing and time zone alignment, and supporting Regulatory Inspection Intelligence processes while contributing to operational quality initiatives. As part of the diverse, international Clinical Quality Inspection team within the Global R&D Quality organization, this individual will help strengthen the R&D Quality Inspection Management System, provide oversight of R&D processes, and lead activities related to GCP regulatory inspections.
Responsibilities
* Develop story boards for key processes and organize mock interviews in preparation for potential Sponsor inspections.
* Ensure a fully informed cross‑functional team (e.g., Quality, Clinical Operations, PV/GPS, GRAAS, DTI) is prepared to support any Regulatory Health Authority inspection worldwide.
* Act as the subject matter expert and primary point of contact for Inspection Management, providing real‑time, proactive advice and guidance.
* Raise significant inspection findings, compliance risks, and impacts to Senior Management.
* Create the inspection management plan for each assigned Regulatory Health Authority inspection in conjunction with the applicable Cross‑Functional Team.
* Manage the R&D inspection framework (Calendars, Distribution Lists, Inspection notifications, SharePoint Sites, Training Content, etc.).
* Liaise with R&D Quality TA Leads to develop appropriate inspection resourcing/scaling and facilities across time‑zones, aligning TA compliance risk identified contact.
* Support Regulatory Inspection Intelligence processes and provide input into Operational Quality Initiatives.
What We Expect Of You
* Degree educated.
* Extensive experience in inspection management within the pharmaceutical or biotechnology industry.
* Strong knowledge of global regulatory requirements and inspection processes.
* Excellent communication and presentation skills.
* Proven ability to work effectively in a cross‑functional team environment.
* Strong organizational and project management skills.
* Experience with SharePoint and other inspection management tools.
* Ability to provide proactive advice and guidance on inspection management.
* Strong problem‑solving skills and the ability to raise issues effectively.
* Ability to travel domestically and/or internationally as needed to attend inspections.
What you can expect of us
* Vast opportunities to learn and advance within a global organization.
* Diverse and inclusive community where teammates are empowered to bring ideas to the table and act.
* Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.
* Flexible work arrangements.
Apply Now
Objects in your future are closer than they appear. Join us at careers.amgen.com.
Amgen is an Equal Opportunity employer and will consider you without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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.
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