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 ComplianceLive
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.
Experience in Medical Device or Combination Product
Certified Quality Auditor (CQA) or equivalent
Travel: 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.
Doctorate degree and 2 years of auditor experience
Masters degree and 6 years of auditor experience
Bachelors degree and 8 years of auditor experience
Associates degree and 10 years of auditor experience
High school diploma / GED and 12 years of auditor experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resourcesThrive
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.