Amgen

Sr. Manager QA

Employer
Amgen
Location
Juncos, PR, US
Posted
Jan 10, 2021
Ref
R-108414
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.

Sr Manager QA

Live

What you will do

Let's do this. Let's change the world. In this vital role you will lead the Quality Operations for AML14 supporting aseptic operations. Sr Mgr QA will provide oversight to the Quality Operations, ensuring staff is well trained and execution is in compliance with procedures and regulations. Actively engaged with projects and deviations impacting Component Prep, Formulation and Filling areas to ensure requirements are complete and Plant QA staff is knowledgeable and trained to timely execute. Accountable for the Quality and Compliance state of the Aseptic Processes in a NON STANDARD SHIFT Operations

AML14 Operations consists of multiple suites encompassing component preparation, formulation and 3 filling lines, working 7 days a week. Area is very dynamic, with a high number of production lots, investigations and projects, required in an expedited timeline.

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
  • Responsible for Major Deviations, CAPAs, CAPA EVs as Quality contact and all associated documents which include GMP document revision, and Quality System records with role of Quality contact.
  • Ensures true Root Cause are identified and appropriate corrective actions are implemented.
  • Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
  • Supports Continual Improvement initiatives, programs and projects
  • Ensures that changes that could potentially impact product quality are assessed according to procedures
  • Ensures that deviations from established procedures are investigated and detailed per procedures
  • Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks
  • Ensures that Quality Assurance personnel are qualified and trained to perform assigned functions in accordance with cGMP with requirements
  • Ensures the Quality Management System is implemented, maintained and reviewed in accordance with cGMP regulations
  • Alerts senior management of significant quality, compliance, supply and safety risks
  • Develops area goals, productivity projects, and tracks progress
  • Develops area budget and handles expenditures
Win

What we expect of you

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

Doctor degree and 2 years of Quality or Manufacturing experience in pharmaceutical, medical device or biotechnology industry
Or

Master's degree and 6 years of Quality or Manufacturing experience in pharmaceutical, medical device or biotechnology industry
Or

Bachelor's degree and 8 years of Quality or Manufacturing experience in pharmaceutical, medical device or biotechnology industry

AND 2 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:
  • Educational background in Life Sciences or Engineering
  • Demonstrated ability to manage supervisors.
  • Experience working with Quality Systems
  • Ability to delegate wisely and effectively.
  • Works effectively with diverse departmental groups.
  • Excellent team development and leadership skills.
  • Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, Quality Control, validation, and process development.
  • Commands respect from team, peers, and management.
  • Detailed knowledge of CFRs, GMPs and pharmaceutical processing and demonstrated ability to apply.
  • Able to make sound, quality decisions independently.
  • Excellent communication (both written and verbal), facilitation, and presentation skills in English and Spanish
  • Skilled in risk management
  • Demonstrate the Amgen Values/Leadership Practices
  • Work under pressure, adapt to changes in priorities
  • Negotiations skills to influence staff and peers to ensure deliverables and results are timely met.
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.

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.