Sr Manager Quality Assurance, Device Supplier Management and Oversight

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.

Sr Manager Quality Assurance Device Supplier Management and Oversight

What you will do

Lets do this. Lets change the world. In this vital role you will program manage remediation of assigned critical external mechanical device suppliers.

• Lead a team of quality professionals overseeing external mechanical device suppliers

• Ensure compliance with scientific regulatory and quality standards across global operations

• Collaborate cross-functionally with teams in External Supply Process Development and Combination Product Quality

• Drive change ensure product quality and create a diverse and inclusive environment

• Monitor quality systems and performance of external device suppliers.

• Define and enforce quality requirements

• Manage supplier quality KPIs and risk escalations

• Manage and develop assigned team members

• Work collaboratively with cross functional teams across Amgen

• Lead impactful cross-functional initiatives

• Foster a culture of continuous improvement and operational excellence

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Medical Device Pharmaceuticals or Biotechnology experience

Or

Masters degree and 6 years of Medical Device Pharmaceuticals or Biotechnology experience

Or

Bachelors degree and 8 years of Medical Device Pharmaceuticals or Biotechnology experience

Or

Associates degree and 10 years of Medical Device Pharmaceuticals or Biotechnology experience

Or

High school diploma / GED and 12 years of Medical Device Pharmaceuticals or Biotechnology 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:

• Degree in Biology Engineering Pharmaceutics Biotechnology or Physics

• 10 years in Medical Device/Pharma/Biotech sectors

• Knowledge of quality systems (batch release complaints risk management)

• Knowledge of global supplier management and device regulations

• Strong leadership communication and problem-solving skills

• Experience leading global teams including during change

• Travel up to 25% domestic and international

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.

Salary Range