Sr. Manager, Clinical Quality Therapeutic Area

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.

Senior Manager, Clinical Quality Therapeutic Area

What you will do

Let’s do this! Let’s change the world! In this vital role you will be a team member on one of the Therapeutic Area (TA) Quality teams, which include Oncology, General Medicine, Rare Disease, and Inflammation/ Biosimilars, and you will report to one of the TA Quality Leads within Clinical & Research Quality (CRQ). As a Senior Manager you will provide proactive, end to end quality oversight through various methods of risk-based quality management activities, including quality by design and real-time analysis of quality data/metrics.

In this important role, you will develop deep knowledge of the TA’s clinical trials and provide oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials. In addition, you will support the management of quality and compliance for specific regions, including clinical trial sites and vendors who work within those regions. The TA

Responsibilities

• Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes

• Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights

• Provide oversight for the development and implementation of Quality Plans

• Establish Regional expertise to ensure quality and compliance to local regulations

• Support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)

• Develop TA-specific Quality Assurance plans that are risk based and efficient. This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits).

• Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness activities, and Inspection Management, and Serious Breaches/ Privacy Issues

• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods).

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of quality experience OR

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

• Bachelor’s degree and 8 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

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 5 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.

• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.<