Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Manager Quality Assurance

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for teams supporting inspection, sampling and testing of incoming raw materials in the Quality Assurance administrative shift. This position provides the opportunity to work directly with Supply Chain while leading all aspects of a team of quality professionals responsible for critical processing of raw materials and components. This is an outstanding opportunity to foster a positive relationship and learning environment between Supply Chain and Quality staff. The Quality Assurance Manager will hire, train, develop, and manage Quality Assurance professionals to successfully deliver to the role to support GMP Manufacturing and to manage change in an effective, efficient and compliant manner.

• Independently determine approach to managing daily operations; guided by general policies and management mentorship.
• Develops and communicates goals and objectives to staff and key partners.
• Develop or contribute to the development of procedures and standards by which others will operate.
• Interpret and complete standards and procedures directly affecting work activities.
• Supervise goal performance and coordinate action for improvement of shift and overall QA performance by championing department OPEX efforts. Assist project teams in establishing priorities, project timelines and in securing resources.
• Actively represent Quality Assurance on incident triage teams or support efforts by providing guidance and/or technical leadership.
• Partner with internal personnel at various management levels to resolve issues, establish direction, obtain resources, and motivate change.
• Representing QA on project and network teams.
• Ensures that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations.
• Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Nonconformance, Corrective Action/Preventative Actions (CAPA), Change Control records, Raw Materials and Drug Substance documentation.
• Trained on daily operations providing direct support to inspection, sampling and testing activities to support the business needs as vital.
• Ensures that changes that could potentially impact product quality are assessed according to procedures.
• Alerts senior management of quality, compliance, supply and safety risks.

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The Quality Assurance professional we seek is a manager with these qualifications.

Basic Qualifications

Doctorate degree

OR

Master’s degree and 3 years of Quality experience

OR

Bachelor’s degree or and 5 years of Quality experience

OR

Associate’s degree and 10 years of Quality experience

Or

High school diploma / GED and 12 years of Quality experience

And

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or advising the allocation of resources

Preferred Qualifications

• Bachelor’s Degree in Life Sciences, Engineering or related field
• 6 + years of quality assurance or combination of quality and manufacturing experience in the biotechnology/pharmaceutical industry
• 3 + years of supervisory/management experience
• Experience in areas of Supply chain, Raw Material sampling/testing, quality control or external supply investigations, CAPA, product release, validation and/or change control
• Experience in regulations, standards and guidelines that apply to biotech manufacturing in a multi-product environment
• Ability to develop meaningful team and staff goals, manage performance and coach and develop staff
• Experience representing Amgen while interacting with representatives of regulatory agencies
• Ability to manage to established timelines and deliver results to meet or exceed department and company goals and objectives.
• Ability to communicate clearly, facilitate discussions and present to audiences at all levels of a site organization
• Ability to solve sophisticated problems and make scientific risk-based decisions
• Ability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations.

Thrive

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve 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

Objects in your future are closer than they appear. Join us.

careers.amgen.com