QA Sr Mgr

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions. 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.

QA Senior Manager

What you will do

Lets do this. Lets change the this vital role you will leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious life-interrupting illnesses.

• 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.

Key Responsibilities

Supplier Oversight:

Monitor quality systems and performance of external device suppliers.

Define and enforce quality requirements.

Manage supplier quality KPIs and risk escalations.

Team Leadership:

Manage and develop assigned team members

Work collaboratively with cross functional teams across Amgen

Tactical Execution:

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 vital attribute professional we seek is a type of person with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of experience
OR
Masters degree and 4 years of experience
OR
Bachelors degree and 6 years of experience
OR
Associates degree and 10 years of experience
OR
High school diploma / GED and 12 years of experience

Preferred Qualifications:

• Degree in Biology Engineering Pharmaceutics Biotechnology or Physics.
• 10 years in Medical Device/pharma/biotech sectors.
• Extensive knowledge of:
• Quality systems (batch release complaints risk management).
• Global supplier management and device regulations.
• Strong leadership communication and problem-solving skills.
• Experience managing 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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