Amgen

Director Quality Compliance

Employer
Amgen
Location
Juncos, PR, US
Posted
Jan 10, 2021
Ref
R-108895
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. Join us.

Director Quality Compliance

Live

What you will do

Let's do this. Let's change the world. In this vital role you will be responsible for managing Quality Compliance projects necessary to achieve corporate and site goals, and the timely communication of identified compliance opportunities to site management leaders.

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
  • Leads projects and activities of the Quality Compliance area. Ensures projects are completed on schedule and site goals are achieved.
  • Leads inspection readiness activities to prepare site for domestic and foreign regulatory agency inspections.
  • Leads audit activities of the Quality Systems processes to ensure compliance with cGMPs, commitments made to Regulatory Authorities, and domestic and foreign regulations.
  • Leads Quality Compliance Specialist in identifying, interpreting, and disseminating new regulatory trends, expectations and compliance documents.
  • Determines the state of compliance with appropriate regulations and developments action plans to correct deficiencies.
  • Serves as a senior Quality Compliance representative in-group meeting (e.g., special task forces) and interacts with other departments in order to achieve goals.
  • Oversees the reviews of Manufacturing Procedures, SOPs, and other documentation related to commitments.
  • Leads and oversees Quality Compliance Specialist's participation in the drafting, review, and approval of responses to domestic and foreign regulatory agency inspections and regulatory deviation reports.
  • Performs tasks, as assigned, to assist in the timely completion of activities associated with the attainment of group, site, and corporate goals.

Win

What we expect of you

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

Doctorate degree and 4 years of Quality experience

OR

Master's degree and 8 years of Quality experience in GMP regulated environment

OR

Bachelor's degree and 10 years of Quality experience in GMP regulated environment

AND

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources.
Beyond that, additional preferred qualifications are:
  • Knowledge of domestic and foreign regulations and practices pertaining to the manufacture and testing of pharmaceutical/biological products, combination products, and medical devices.
  • Vast experience leading regulatory and or internal inspections
  • Project management skills
  • Negotiating skills.
  • Fully Bilingual
  • Goal setting and strategic planning.
  • Written and verbal communication skills including technical writing skills.
  • Analytical problem solving.
  • Presentation skills.
  • Coaching, mentoring and counseling skills.
  • Leadership and team-building skills.
  • Managing change

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


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.