Senior Manager, Change Control Global Process Owner

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Senior Manager, Change Control

Live

What you will do

Lets do this! Lets change the world!

The Quality Management System is the foundation of all that we manufacture, test, and store at Amgen to support our biggest mission, to serve the patients. This position will be responsible for the global Change Control process lead a network of Change Control Subject Matter professionals to assure product and process changes made at Amgen are controlled, effective, and efficient. This position sits in Quality Systems and is part of a very versatile team.

Accountabilities:

Owns and ensures GXP Change Control is effective globally

Effectively manages change control process to drive agile, efficient, effective and sustainable changes

Assures Change Impact is considered across products, platforms, life cycle phases, supply chain, and processes (i.e. combination products)

Responsibilities:

Owns Process Standard, Process Overview and Multisite SOP and ensures alignment with document hierarchy and document templates

Owns and acts upon performance metrics and process issues, implementing actions to drive continuous improvement and escalating to management for support if needed

Leads and coordinates critical activities to ensure compliance throughout the network: gap assessments, commitments, response to audit & inspection findings and deviations

Leads continuous process improvements and partners with network SMEs on key initiatives

Supports regulatory inspections and audits

Maintains assigned global quality process in compliance with all applicable global regulations and global Amgen specific requirements

Monitors GMP Surveillance and takes necessary actions to align process to applicable new or revised regulatory requirements

Leads network and cascades requirements and QMS architecture down to all applicable sites and functions. Notifies sites early of changes to ensure consistency

Strategic Contribution & Authority

Defines process strategy and provides mentorship to Network SMEs and applicable leadership

Has visibility and oversight to major changes across network to ensure applicability and consistency

Connects externally to assure alignment on expectations with regulators and industry

Integrates Change Control in Quality System demonstrating digital innovation

Win

What we expect of you

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

Qualifications - Minimum Requirements

• Doctorate degree & 4 years of Quality experience OR

• Masters degree & 6 years of Quality experience OR

• Bachelors degree & 8 years of Quality experience AND

• 4 years of leading quality initiatives or processes across a global network

• English language fluency

• Experience in a pharmaceutical/drug/device manufacturing environment

Preferred Requirements

• 7+ years of leadership experience leading teams across global sites and functions

• Advanced knowledge Quality Management Systems, especially Change Control

• Experience in a pharmaceutical/drug/device manufacturing environment

• Strong understanding of Combination Product Change Control needs

• Ability to balance and interpret global priorities and market appropriate requirements to ensure Quality System elements are Agile and phase appropriate

• Autonomous problem solver, willing to take informed and appropriate risks

• Broad and deep knowledge of the Amgen Quality Management System (QMS)

• Understand global, regional and local commercial business (speak commercial)

• Cultural awareness and dexterity

• Other language skills are an advantage

• Innovation mentality with aptitude for developing ideas into measurable objectives

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.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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.