Amgen Jobs

Mobile Amgen Logo

Job Information

Amgen Manager Quality (Fixed Term) in Mexico City, Mexico


If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. We have proudly achieve certifications as Great Place to Work and Equidad MX . It’s time for a career you can be proud of. Join us.

Manager Quality (Fixed Term: 1 year)


What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for

  • Management of Quality Systems: Documentation, Deviations/CAPA, Change Controls, Audits.

  • Responsible for Quality oversight of activities at Amgen Logistic Service Providers.

  • Cold Chain Management.

  • Additional responsibilities include management and evaluation of compliance issues/regulations, assure progress against commitments to regulatory agencies, identify compliance gaps and lead focused teams to resolve compliance issues, provide written compliance assessments to management on request, and interpret global regulations.

  • Management of Regulatory Submissions to COFEPRIS.

  • Develop and maintain Quality System.

  • Develop reports and provide the vital communications throughout the organizations as required to ensure effective information sharing.

  • Support Amgen in all quality matters related to Amgen’s products imported and distributed in country.

  • Perform Final Product Disposition.

  • Cross-train with other peers and serve as back up for other countries within the region

  • Acts as a back up and advisor to the Responsible Pharmacist for Quality matters.

Key Behaviors:

  • In-depth disciplinary knowledge; demonstrates business insight and subject matter expertise.

  • Problem Solving.

  • Autonomy.

  • Uses positive relationships to identify requirements and potential opportunities.

  • Provides leadership, mentorship and advice in own field.

  • Works with resource managers from across the organization to optimally acquire and prioritize to complete programs and projects on time.

Minimum Requirements

  • Doctorate degree OR

  • Master’s degree and 3 years of experience similar position in an international environment Or

  • Bachelor’s degree and 5 years of experience similar position in an international environment Or

  • Associate’s degree and 10 years of experience similar position in an international environment Or

  • High school diploma / GED and 12 years of experience similar position in an international environment,

  • And Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.

  • Proficiency in English, both in written and verbal communication.

Preferred Requirements

  • 3 or more years of relevant work experience within the pharmaceutical industry, preferably – experience with biologics, vaccines.

  • Must have strong knowledge and understanding of GDP requirements, cold chain transportation and storage, local regulatory requirements.

  • Experience in regulatory inspections, equipment qualification, risk assessments, change control.

  • Experience in providing support, troubleshooting unit operations, and resolving and documenting investigations to support GDP tasks.


Some of the vast rewards of working here

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.

  • Full support and career-development resources to expand your skills, improve your expertise, and maximize your potential along your career journey.

  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.

  • Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor.

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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.

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 cancer, kidney diseases, 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.