Amgen Jobs

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.

Quality Compliance Manager

What you will do

Let’s do this. Let’s change the world. In this vital role, the Quality Compliance Manager will support the R&D quality organization and the Process Document Management (PDM) team by providing expert support for creating and managing R&D controlled processes and documents. The team is responsible for maintaining R&D standards and contributing to the compliant execution of R&D processes through clear and appropriate controlled documentation. The PDM team also provides R&D oversight for the electronic document management system, including enhancements and improvements.

The Quality Compliance Manager will play a key role in managing R&D-controlled documents by helping to strengthen and advance Amgen’s R&D Quality Management System. The Quality Compliance Manager contributes to implementing strategies and providing leadership to ensure excellence in controlled document management. As an integral team member working globally with QCL&P team members and Business Process Owners to ensure compliance with regulations and other requirements through:

• Contributing to and implementing strategies for R&D-controlled document management.

• Establishing and implementing end-to-end processes and standards for controlled documents.

• Leading complex cross-functional documentation change and process improvement projects across R&D.

• Providing input and technical expertise to establish, implement, maintain, and adapt document hierarchy.

• Implementing controlled process creation/revision activities.

• Providing quality expertise and guidance to R&D functions and business process owners to ensure complete, clear, and well-managed documents.

• Leading targeted documentation review and improvement efforts.

• Partnering with process owners, training leadership, and business process management to implement robust process documentation change control and communication strategies.

• Advancing process-document changes to address incidents, deviations, audits, and inspection findings.

• Finding opportunities for Enterprise Application implementations to ensure consistency across functional boundaries.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 2 years of Quality/Compliance/Process Management experience OR

• Bachelor’s degree and 4 years of Quality/Compliance/Process Management experience OR

• Associate’s degree and 8 years of Quality/Compliance/Process Management experience Or

• High school diploma / GED and 10 years of Quality/Compliance/Process Management experience

Preferred Qualifications:

• Advanced Degree: Eight years in Quality Management, Compliance, or related areas within the pharmaceutical/biotech industry.

• Process management, documentation, and modeling experience.

• Proven experience in change and project management

• Knowledge of global regulations impacting R&D activities

• Quality Management System oversight and implementation experience

• Knowledge of controlled document management systems and Good Document Management practices.

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

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.