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 leading and supervising the Quality Assurance (QA) team in our AML Supply Chain and Incoming Quality – part of the Drug Substance Operations reporting to a night shift as a non-standard operation. The QA Manager will lead the Plant Quality Assurance staff overseeing the AML Warehousing and Incoming sampling/testing activities occurring in Supply Chain /Incoming areas such as receiving, warehouse, shipping, material transfer, and sampling / testing, among others. Also provides Quality Floor support to the AML Warehouse and Incoming, assists in the resolution of issues, and manages GMP records. The area is very dynamic with a high number of material and product movements from and to all AML buildings, investigations and projects in a fast-paced environment.

Specific responsibilities include but are not limited to:

• Direct management of on-the-floor QA activities including but not limited to oversight of the Warehouse and Incoming processes, batch record review, deviation investigation, change controls and SOP revisions, among others.
• Strong collaboration and partnership cross functionally (i.e. Manufacturing, Process Development, Regulatory, Supply Chain, Incoming QC, External Supply, etc.) to ensure the Quality Management System processes are implemented in accordance with established procedures. Ensuring operations are in full cGxP compliance.
• Strategic advisor to senior management of quality, compliance, supply, and safety risks.
• Mentoring, coaching, and developing staff to build highly skilled, diverse, and inclusive teams.
• Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities.
• Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement.
• Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages.
• Resolve critical gaps in the organization’s internal capabilities and skillsets, including strategic external recruiting as needed. Identifying also diverse, qualified successors for key positions.
• Ensure maintenance and re-validation of systems with expertise in EBR, SAP, Trackwise, Maximo systems.
• Review and approve process validation protocols and reports for Warehouse and Incoming processes.

Win

What we expect of you

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

Doctorate degree

OR

Master’s degree and 3 years of Quality or Manufacturing support experience

Or

Bachelor’s degree and 5 years of Quality or Manufacturing support experience

Or

Associate’s degree and 10 years of Quality or Manufacturing support experience

Or

High School Diploma/GED and 12 years of Quality or Manufacturing support experience

And

Previous managerial experience directly handling people and/or experience leading teams, projects, programs or managing the allocation of resources.

Additional Preferred Qualifications are:

• Educational background in Life Science or Engineering
• Experience leading cross functional teams with the influencing and negotiating skills
• Validated expertise in Quality Systems such as Deviations, CAPA and Change Control
• Experience in computer systems validation or computer systems quality assurance
• Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements
• Strong organizational, project management and change management skills
• Ability to motivate staff and manage and distribute workloads
• Demonstrate ability to interact with regulatory agencies
• Solid word processing, presentation, database and spreadsheet application skills
• Strong communication skills (both written and oral), and comprehend in English and Spanish
• Proven skill in working independently and to effectively interact with all levels throughout the organization
• Advanced data trending & evaluation and ability to evaluate compliance issues

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also 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 maximize 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