R&D Quality Senior Manager

Career Category

Job Description

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 mission—to serve patients living with serious illnesses���drives 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.

R&D Quality Senior Manager

What you will do

Let’s do this! Let’s change the world! In this vital role the R&D Quality Senior Manager will play a crucial part in ensuring our organization's compliance with regulatory standards and preparing and coordinating a cross-functional team for Regulatory Health Authority inspections globally. The role also involves developing inspection management plans for each identified Regulatory Health Authority inspection, managing the R&D inspection framework, and ensuring appropriate inspection resourcing and alignment across time zones. Additionally, the individual will support Regulatory Inspection Intelligence processes and contribute to operational quality initiatives. The Clinical Quality Inspection team is a diverse international team within the Global R&D Quality organization. We are in charge of strengthening and enhancing the R&D Quality Inspection Management System, providing Quality oversight on R&D processes, and leading activities related to GCP regulatory inspections.

Responsibilities:

• Ensures, that because of inspection preparation activities, story boards are being developed for key processes and activities. Organizes presentations of the story boards and mock interviews in preparation of potential Sponsor inspections.

• Ensures that a cross-functional team (e.g. Quality, Clinical Operations, other functional areas, PV/GPS, GRAAS, DTI, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.

• Acts as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management to provide real-time, proactive advice and guidance.

• Raises potentially significant inspection findings/compliance risks/impact to Senior Management.

• Develops the inspection management plan for each assigned and identified 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, and align TA compliance risk identified contact (CT-RACT, specific risk management items e.g. imaging approaches) .

• Support Regulatory Inspection Intelligence processes and provide input into Operational Quality Initiatives.

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:

• Doctorate degree and 2 years of quality experience OR

• Master’s degree and 4 years of quality experience OR

• Bachelor’s degree and 6 years of quality experience OR

• Associate’s degree and 10 years of quality experience OR

• High school diploma / GED and 12 years of quality experience

Preferred Qualifications:

• 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