Career Category

Job Description

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 reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Sr Specialist Quality Complaints

Live

What you will do

Let’s do this! Let’s change the world!

Job Description

Amgen is seeking a Sr. Specialist Quality Complaints – Training and IS Systems as part of the broader Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and completes the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Specialist establishes and leads robust onboarding curriculum and training programs for members of the Product Complaints and Surveillance team. Leads development and maintenance of complaint staff training curriculum and content. Determines regulatory requirements for complaints curriculum and any action which may be necessary to ensure compliance with internal and external requirements.

Determines regulatory requirements (e.g. Data Integrity) for complaint IS systems and any action which may be necessary to show due diligence with Complaints IS systems. Establishes and performs data monitoring for complaint IS systems.

Key Responsibilities:

• Leads cross-functional teams to analyze, outline, and implement the strategy for complaint staff onboarding and ongoing training requirements

• Demonstrates in-depth knowledge of complaint processes, systems, and requirements along with subject matter expertise to inform the right content and standard methodologies

• Works closely with Operations Learning and Performance to develop strategy, content, and delivery mechanism to ensure alignment with corporate and regulatory requirements

• Manages and drives continuous improvement for complaint staff training curriculum, onboarding, and related content

• Drives Operational Excellence and champions change

• Directs interactions with health and regulatory authorities during inspections, speaking on behalf of Amgen

• Applies in-depth knowledge and subject matter expertise to determine the steps necessary to advance the complaints IS systems

• Leads cross-functional teams in analysis of complaint IS system issues and the necessary steps to address both immediate and future anticipated issues

• Interprets IS regulatory requirements, performs informed gap assessments for complaints IS systems, and translates into SOP requirements

• Focuses on ways to predict and prevent, using leading indicators and data insights to proactively find opportunities and challenges

• Sets project timelines and priorities

• Partners with key collaborators to include Medical Communication, Amgen Global Safety with shared IS systems, ensuring quality requirements are met

• Responsible for Business Continuity Plans for Complaints IS Systems

• Assists GPO to manage Process Standard, Process Overview and Multisite SOP to ensure alignment with document hierarchy and document templates.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek will have these qualifications.

Basic Qualifications

Doctorate degree and 2 years of Quality experience

Or

Master’s degree and 6 years of Quality experience

Or

Bachelor’s degree and 8 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

Preferred Qualifications

• 8+ years of quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelor’s Degree in a Science Field

• Leadership skills and the ability to oversee multiple projects simultaneously

• Ability to successfully manage workload to timelines

• Familiarity with basic project management tools

• Ability to negotiate a position after taking feedback from multiple sources

• Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment with site, functional, and executive leadership

• Experience in driving decision making by using decision making principles

• Understanding of industry requirements/expectations of a Quality Management System (QMS) Training Program

• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

• Understanding of IS Systems related to management of quality processes

• Ability to travel +/- 10% of time to domestic and international Amgen sites

Thrive

What you can expect of us

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.

• 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