Deviation / CAPA Site SME

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.



Deviation/ CAPA Site SME

What you will do



Let’s do this. Let’s change the world. In this vital role you will manage the process that transforms issues into opportunities, ensuring every investigation and corrective action strengthens our systems and processes. You’ll lead problem solving with rigor and creativity, manage the process to keep it inspection-ready, and be the go-to guide for users who need support. If you’re passionate about quality and love turning lessons into lasting change, this is your role.



Responsibilities:

Purposefully monitors execution of the quality process and communicates performance to GPO/Users & Management

Ensures inspection readiness and applicable local procedures are in alignment with quality process requirements and QMS architecture

Attends collaboration group meetings and represents site/functional challenges, lessons learned, audit and inspection findings and best practices

Reviews standard, and may author or QA process documentation or training materials

On-boards new users; provides training, facilitates learning groups and is a coach/mentor to users

Escalates performance issues and trends to the GPO, site management reviews, applicable SMEs and site/functional/regional management

Represents process during audits and regulatory agency inspections and engages with GPO to address commitments.

Engages with GPO when commitments are made after regulatory inspections

Understands process changes and communicates impact to management/users as well as participating in, or leading, process improvements.

Own site/function NCs, CAPA/EVs, and change records for process

Develops and owns site/region specific commitments for process

Is responsible for collecting, calculating, analyzing, and interpreting performance metrics to provide actionable insights that drive data-informed decision-making.

Owns or performs Quality Assurance (QA) review of quality records to support the global network

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 go getter with these qualifications.



Basic Qualifications:



Doctorate degree



Or



Master’s degree and 2 years of Quality experience



Or



Bachelor’s degree and 4 years of Quality experience



Or



Associate’s degree and 8 years of Quality experience



Or



High school diploma / GED and 10 years of Quality experience



Preferred Qualifications:

Hands-on experience with Quality Management Systems (QMS) and applications. (DQMS, TrackWise, S2)

Ability to maintain inspection readiness and respond to audit/regulatory findings.

Experience creating and utilizing AI technology

Strong analytical thinking to identify process inefficiencies and risks.

Experience in root cause analysis and CAPA (Corrective and Preventive Actions).

Skilled at building consensus and driving process adoption across diverse teams.

Ability to mentor, coach, and train new users effectively.

Confident in presenting during audits, inspections, and management reviews.

Strong interpersonal skills to maintain effective cross-functional relationships.

Proven ability to lead process improvements at site, functional, or regional levels.

What you can expect from 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, we’ll 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.



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