Amgen

Director Quality Assurance - Drug Product

Employer
Amgen
Location
Juncos, PR, US
Posted
Jan 10, 2021
Ref
R-108357
Required Education
Bachelors Degree
Position Type
Full time
HOW MIGHT YOU DEFY IMAGINATION?

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 read over 10 million patients worldwide. It's time for a career you can be proud of.

Director Quality Assurance - Drug Product
Live

What you will do

Let's do this. Let's change the world! In this vital role you will lead the AML Quality organization that oversees the Inspection and Packaging Drug Product Manufacturing plant. This role will ensure product quality standards are met in compliance with regulatory requirements. As part of this leadership role, you will develop strong teams and support staff in career development. The scope of work and responsibility includes commercial process development, technology transfer, regulatory CMC documents, inspection, assembly of combination products, and packaging operations, and interactions with regulatory agency inspectors. In addition, the position will lead and support efforts to develop and implement new technologies and identify and implement productivity initiatives and business strategies to drive organizational efficiency.
  • Ensures that licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations and specifications.
  • Leads and directs the Quality Assurance function for AML Drug Product Manufacturing plant
  • Ensures the Quality review, approval and tracking of cGMP quality-related systems and processes such as procedures, documents and records, including non-conformances, CAPAs, Change Controls, and validations.
  • Provides Quality oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards.
  • Ensures that relevant systems, processes, procedures and assays are validated.
  • Ensures adequate Quality Assurance coverage and oversight for Drug Product and Combination Product operations.
  • Serves as the quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd party auditors.
  • Alerts management of significant quality, compliance, supply and safety risks.
  • Implements and periodically reviews the Quality Management System and performance metrics to identify, report, address and correct all quality risks.
  • Ensures that there is an adequate number of qualified personnel who possess an adequate combination of education, experience and training to perform assigned Quality oversight functions accordance with requirements and specifications.
  • Manages department expenditures within budget.
  • Support Continues Improvement initiatives, programs and projects of the Quality System.
Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Director Quality professional we seek is a strong leader with these qualifications.

Doctorate degree and 4 years of Manufacturing and/or Quality support experience in a GMP regulated industry
Or

Master's degree and 8 years of Manufacturing and/or Quality support experience in a GMP regulated industry
Or

Bachelor's degree and 10 years of Manufacturing and/or Quality support experience in a GMP regulated industry
And

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

Beyond that, additional preferred qualifications are:
  • 10+ years of Manufacturing and/or Quality leading experience.
  • Life Science and/or Engineering educational background.
  • Knowledge of and previous experience in various Quality Operations.
  • Experience in combination product or medical device quality processes
  • Superb knowledge of cGMP's and CFR's EC GMPs.
  • Excellent verbal and written communication skills (English and Spanish)
  • Strong group presentation skills. Previous experience in project management.
  • Previous experience in presentations to both large and small groups.
  • Good analytical/critical thinking skills with an experienced global perspective.
  • Strong persuasion and negotiation skills and the ability to interact successfully and partner with management within and outside of Quality Assurance department.
  • Team development and leadership skills.
Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • 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
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: careers.amgen.com
Equal Opportunity Statement

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 a 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 an 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.