Amgen

Career Category

Operations

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Quality Compliance Manager – Process Excellence, Continuous Improvement & Innovation

What you will do

Let’s do this. Let’s change the world. l The Quality Compliance Manager is a global role and part of the Continuous Improvement & Innovation team for the R&D Quality Organization. This role will support processes and efforts related to continuous improvement and change management.

They will be a vital part of Amgen's Quality Management System, providing expert support to create and manage R&D controlled processes aimed at continuous improvement through the application of standard methodologies (Lean, DMAIC, Six Sigma).

The Quality Compliance Manager will contribute to implementing strategies and providing leadership to ensure excellence in R&D Quality Processes. As an integral team member working globally with Business Process Owners to ensure compliance with regulations and other requirements. This individual will be part of supporting the digital quality management system (DQMS) as an SME to support new and the core processes managed in Quality.

Roles & Responsibilities:

This role will work both independently and in a team environment to foster collaborative relationships with R&D and OCMO to assess the current state of quality, identify potential quality risks, and explore innovative strategies for enhancing the Quality Management System (QMS) in a fast-paced R&D setting. they will also be responsible for any innovative, process excellence strategy activities.

• Design, implement, and/or support proactive, comprehensive, risk-based quality improvement strategies for R&D, OCMO, and R&D Quality through established processes and methodologies (Lean, DMAIC, Six Sigma, Kaizen, Quality by Design, etc.).
• Supervise improvement initiatives for R&D Quality informed by insights from Amgen's quality system, including audits/inspection findings, deviations, and quality trend analyses.
• Serves as a cornerstone of quality and innovative approaches to enhance the QMS within an agile R&D environment.
• Lead Organizational Change Management (OCM) initiatives for projects spearheaded by R&D Quality.
• Provide input and technical expertise to establish, implement, maintain, and adapt continuous improvement methodologies, for example Six Sigma, Lean, Kaizen and ADKAR.
• Assist OCM strategies for initiatives driven by Operations and R&D/OCMO that may affect the R&D Quality Organization.
• Provide quality expertise and guidance to R&D functions and business process owners to ensure comprehensive, clear, and well-managed organizational changes
• Partner with process owners, training leadership, and business process management to implement robust communication strategies and training
• Manage, organize and analyze data through different systems, tools, or platforms, including Excel and Smartsheet

What we expect of you

Basic Qualifications and Experience:

• Master’s degree with 4-6 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred
• Bachelor’s degree and 6-8 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred.
• Diploma Degree and 10-12 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred.

Functional Skills:

Must-Have Skills:

• Exceptional attention to detail and accuracy in all deliverables.
• Ability to work independently and proactively in a fast-paced environment.
• Proficiency in Smartsheet, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams, WebEx)

Good-to-Have Skills:

• Familiarity with project management tools and methodologies.
• Knowledge of GCP, GLP and/or GPvP.
• Experience working in a multinational environment with global teams.

Soft Skills:

• Excellent verbal and written communication skills.
• High degree of professionalism and interpersonal skills.
• Strong problem-solving abilities and adaptability to changing priorities.
• Collaborative attitude and ability to build positive relationships across diverse teams.
• Resilience, discretion, and the ability to thrive under pressure

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 with 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.

.

Read Full Description