QA Manager AML-23

Juncos, PR, US
Nov 05, 2020
Required Education
Bachelors Degree
Position Type
Full time

In support of Amgen's Quality Assurance program leads all aspects of the operations of a specific area(s) of responsibility.

Specific responsibilities include but are not limited to:
  • Responsible for hiring, training, supervising and performance management of staff.
  • May perform or lead all aspects of the following functions:
  • Review and approve product MPs
  • Approve process validation protocols and reports for Mfg. processes.
  • Approve Environmental Characterization reports
  • Approve planned incidents
  • Represent QA on NPI team
  • Lead investigations
  • Lead plant audits, participate in site audits
  • Approve change-over completion
  • May perform work of QA Specialist

Basic education & experience:

Doctorate degree


Master's degree and 3 years of Quality experience


Bachelor's degree and 5 years of Quality experience and previous managerial experience directly handling people and/or experience leading teams, projects, programs or advising the allocation of resources.

Preferred qualifications:
  • Project leadership skills
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Initiate and lead cross functional teams.
  • Collaborate and connect with higher level outside resources.
  • Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, validation, and process development.
  • Solid understanding of proven dosage manufacturing
  • Strong communication (both written and oral), facilitation, and presentation skills.
  • Strong skill in working independently and to efficiently interact with various levels.
  • Ability to lead and influence staff outside own organization.
  • Ability to empower staff and lead and distribute workloads.
  • Able to lead performance issues and conflict
  • Ability to provide direction and establish goals for individual staff members and work group.
  • Ability to evaluate documentation/ operations according to company and regulatory guidelines
  • Ability to interact with regulatory agencies
  • Demonstrate the Amgen Values/Leadership Practices

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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 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.