Deviation/CAPA Site SME

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.

Deviation/ CAPA Site SME

What you will do

Lets do this. Lets change the this vital role you will manage the process that transforms issues into opportunities ensuring every investigation and corrective action strengthens our systems and processes. Youll 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 youre 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

Masters degree and 2 years of Quality experience

Or

Bachelors degree and 4 years of Quality experience

Or

Associates 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 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.

Salary Range