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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. 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 SR MANAGER EXTERNAL SUPPLY QUALITY (ESQ) - SUPPLIER QUALITY MANAGEMENT

What you will do

Lets do this. Lets change the this vital role you will serve as the quality lead and subject matter expert for critical global suppliers of GMP raw materials specifically Single Use Resins and Filters (SURF). You will own the end-to-end quality oversight of assigned suppliersfrom onboarding through ongoing performance monitoring to disengagementensuring compliance reliability and continuous improvement. You will also act as the primary quality contact for internal stakeholders supporting issue resolution supplier strategy and cross-functional initiatives. This role offers a unique chance to make a global impact while developing deep expertise in SURF materials and external quality systems.

• Act as the quality lead for supplier relationships from onboarding through disengagement ensuring performance through robust proactive monitoring technical site visits and continuous improvement.
• Perform proactive quality management of suppliers ensuring compliance with global regulatory standards including but not limited to GDP GMP ISO etc and Amgens industry leading expectations.
• Review and approve quality documentation including Quality Agreements deviations supplier investigations CAPAs CAPA EVs supplier change notifications and change controls with a sharp eye for risk and compliance.
• Participate in and/or lead supplier audits and collaborate with internal and external partners to implement corrective and preventive actions.
• Prepare Amgen sites and suppliers for audits and inspections including development of inspection playbooks. Represent Amgen/ESQ during such audits and inspections - owning our quality story with confidence and clarity.
• Identify and mitigate risks at the supplier and/or escalate to management.
• Perform Person in Plant activities as deemed appropriate.
• Drive audit commitments to completion.
• Act as a key quality partner to External Supply Manufacturing Supply Chain Material Sciences Engineering Technical Authority (ETA) Process Development and other internal functions.
• Take the lead and/or participate in cross-functional initiatives and continuous improvement projects shaping the future of supplier quality at Amgen.
• Roles require 20% travel both domestic and international travel.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The QA Senior Manager External Supply Quality professional we seek is a collaborative leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Quality experience OR
• Associates degree and 10 years of Quality experience OR
• Bachelors degree and 8 years of Quality experience OR
• Masters degree and 6 years of Quality experience OR
• Doctorate degree and 2 years of Quality experience OR

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:

• Educational background in Life Sciences
• Strong technical knowledge and experience within operations in the pharmaceutical or GMP-regulated industry
• Relevant work experience within Drug Substance and Drug Product operations ideally with single use systems and platforms
• 5 years of experience overseeing quality of suppliers
• Robust problem-solving and root-cause analysis experience
• Strong continuous improvement mentality
• Strong compliance quality and regulatory knowledge with critical thinking inquisitive with an end-to-end mentality
• Strong communication skills with proficiency in the English language and collaborative cross-functionally behavior
• Strong report writing and presentation skills
• Experience driving decision-making by using DAI principles
• Understanding of industry requirements/expectations of a QMS
• Savvy with data and Artificial Intelligence tools
• Understanding of the applicable manufacturing/testing processes (i.e. API Drug Substance Drug Product Packaging Device manufacturing processes)

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