Sr. Manager, Clinical Quality Therapeutic Area

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll 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

Lets do this! Lets 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 TAs 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 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

• Masters degree and 6 years of quality experience OR

• Bachelors degree and 8 years of quality experience OR

• Associates 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.

• Thorough understanding of Clinical R&D activities and Global Regulations.

• Knowledge of the Regulatory Submission and Inspection Management procedures.

• Quality Oversight of Clinical Trials including clinical trial protocol development execution and submissions.

• People leadership and managerial expertise.

• Excellent verbal and written communication skills including strong business writing abilities and active listening.

• Ability to transform business and customer feedback into clear efficient processes using a straightforward language and format.

• Strong analytical critical-thinking and decision-making abilities.

• Capability to understand and articulate technical concepts and literature in spoken and written English.

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 well 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

Apply now and make a lasting impact with the Amgen team.

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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