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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-solving skills and the ability to raise issues effectively.

+ Ability to travel domestically and/or internationally, depending on business needs, to attend inspections as needed.

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 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:

+ A 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

+ Flexible work models, including remote and hybrid work arrangements, where possible

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

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.

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.

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