Senior Manager QA

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.

Let’s do this. Let’s change the world. In this vital role you will be responsible for overseeing and enhancing our Quality Management System to ensure continuous improvement, compliance with relevant standards, and the highest level of customer satisfaction. This role requires a strategic problem solver with strong organizational and problem-solving skills, a commitment to teamwork, and a focus on customer needs.

• QMS Oversight: Lead the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with industry standards and best practices.
• Audit Management: Plan, conduct, and oversee internal and external audits to ensure compliance with QMS requirements and identify areas for improvement.
• Continuous Improvement: Drive continuous improvement initiatives across the organization, applying quality management tools and methodologies such as Six Sigma and Lean.
• Regulatory Compliance: Ensure compliance with relevant quality standards (e.g., ISO 9001) and regulatory requirements.
• Training and Development: Develop and deliver training programs to ensure that all employees are knowledgeable about QMS processes and best practices.
• Collaborator Engagement: Collaborate with internal and external collaborators to address quality-related issues and ensure customer satisfaction.
• Data Analysis: Analyze quality data to identify trends, root causes, and opportunities for improvement.
• Documentation: Maintain accurate and up-to-date QMS documentation, including policies, procedures, and records.
• Team Leadership: Lead and mentor a team of quality professionals, fostering a culture of excellence and continuous improvement.

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Master’s degree and 8 to 10 years of relevant field (e.g., Quality Management, Engineering, Business Administration experience OR
• Bachelor’s degree and 10 to 14 years ofrelevant field (e.g., Quality Management, Engineering, Business Administration experience OR
• Diploma and 14 to 18 years of relevant field (e.g., Quality Management, Engineering, Business Administration experience
• Certifications in quality management (e.g., ISO 9001, Six Sigma) are highly desirable.
• Proven experience in conducting audits and managing QMS-related projects.
• Strong organizational skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
• Excellent adaptability, with the ability to quickly grasp new concepts and react to changes in a rapidly evolving environment.
• Strong teamwork skills, with the ability to work well with others and contribute to a positive team environment.
• Strong problem-solving skills, with the ability to analyze and resolve issues related to documentation and processes.
• Customer-focused mindset, with a commitment to understanding and meeting the needs of internal and external collaborators.

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.

for a career that defies imagination

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

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.