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Senior Manager Corporate Quality Compliance (Remote)

Employer
Amgen
Location
Los Angeles, CA
Start date
Sep 23, 2023

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Senior Manager Corporate Quality Compliance

Live

What you will do

Lets do this! Lets 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 escalate 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 escalates 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

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

Additional Requirements:

  • Experience in Medical Device or Combination Product

  • Certified Quality Auditor (CQA) or equivalent

  • Travel: Approximately 50%

Win

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

Masters degree and 6 years of auditor experience

Or

Bachelors degree and 8 years of auditor experience

Or

Associates degree and 10 years of auditor experience

Or

High school diploma / GED and 12 years of auditor experience

And

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $143,192 - $170,286.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:

  • 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 and bi-annual company-wide shutdowns

  • Flexible work models, including remote 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
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Telephone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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