Senior Manager Corporate Quality Compliance

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.

Senior Manager Global Quality Compliance

What you will do

Let’s do this. Let’s change the world.

• Responsible for leading, directing and managing the Global Quality Compliance (GQC) functional area(s).

• Develops and manages the GQC audit program and annual audit plans to ensure that Amgen sites, Contract facilities, Quality Management Systems and Affiliates are periodically audited to assess compliance all applicable regulations and to identify potential risks.

• Leads or participates in critical GQC Audits of Amgen Quality Management System, Amgen sites, Contract facilities, Affiliates and Critical Service providers, to identify and raise top compliance risks.

• Ensures assessment of the state of compliance with appropriate regulations and participation in the assessment of action plans to correct deficiencies.

• Provides technical and organizational leadership toward resolving site and multi-site compliance issues.

• Alerts executive management of significant quality, and compliance risks.

• Provides support for domestic and foreign regulatory agency site inspections, as needed.

• Serves as senior GQC representative on cross-functional teams and interacts with other departments in order to achieve goals.

• Interacts with other functional leads to ensure that operational standards, strategies, and direction meet organizational goals/objectives and are aligned with existing regulations and regulatory expectation.

• Monitors and advances to senior management and management review established metrics representative of the health of the audits and inspections process.

• Supports continual improvement initiatives, programs, and projects including owning and executing CAPAs, owning and revising documents, and managing change controls

• Reviews and approves audit reports as audit management from GQC auditors.

Additional Requirements:

• Experience with Aseptic Processing, Drug Product

• Certified Quality Auditor (CQA) or equivalent

• Travel: Domestic and International Approximately 50%

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 and 2 years of auditor experience OR

• Master’s degree and 6 years of auditor experience OR

• Bachelor’s degree and 8 years of auditor experience OR

• Associate’s degree and 10 years of auditor experience OR

• High school diploma / GED and 12 years of auditor experience

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

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, 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.

careers.amgen.com

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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.