Quality Assurance Manager - Global Distribution and Affiliates

Manager IDQ Affiliates & Global Distribution Quality

Career Category

Quality

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.

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and make people’s lives easier, fuller, and longer. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting edge of innovation, using technology and human genetic data to push beyond what’s known today.

What you will do

Role Description:

In this role, you will serve patients through internal collaboration with Amgen’s global quality teams, manufacturing sites, commercial supply chains, Amgen affiliates, warehouses, and external logistic partners in various regions and countries. You will contribute to ensuring high-quality and right-first-time quality systems activities at Amgen, build and support a resilient supply network, and conclude with a positive patient experience.

The Manager of Quality Assurance will support the implementation and management of quality assurance activities at the Amgen Technology and Innovation Center, as well as will be responsible for leading a team of quality professionals who will maintain and approve various quality documents, including but not limited to Quality documentation and metrics, validation documentation, investigations, CAPA and audit records, and quality agreements. This role will involve collaboration with various Amgen teams to ensure seamless handoffs between teams.

Roles & Responsibilities:

• Oversee a group of 5 to 10 staff, ensuring their activities and priorities are managed in a compliant, structured manner.
• Ensure team members are appropriately qualified and trained to perform quality activities per company procedures.
• Conduct goal setting, performance reviews, and compensation planning
• Develop, implement, and maintain the quality records in compliance with industry standards and regulatory requirements.
• Continuously improve documentation processes to enhance efficiency and quality by applying lean principles and automation
• Conduct internal audits and coordinate external audits to ensure quality compliance.
• Analyze data and metrics to identify trends and areas for improvement within the quality systems.
• Work cross-functionally and cross-regionally with various Amgen teams and stakeholders to ensure seamless task transitions and continuity across groups.
• Prepare, review, and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.
• Provide support for domestic and foreign regulatory agency site inspections.
• 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 is a [type of person] with these qualifications.

Basic Qualifications and Experience:

• Bachelor’s degree with 8 to 13 years of experience in quality management systems or a related field

Must-Have Skills:

• Working foundation in quality assurance roles and proven team leader.
• Minimum of 2 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
• Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them

Good-to-Have Skills:

• Experience in investigations, project management and trending and analysis
• Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).
• Proven experience in designing and/or improving processes at conceptual level
• Desire to partner with internal and external stakeholders across teams
• Understanding of industry requirements/expectations of a robust Quality Management System and documentation.
• Solid background on digital eco system.

Soft Skills:

• Excellent analytical and troubleshooting skills.
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation.
• Ability to manage multiple priorities successfully.
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills.

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

for a career that defies imagination

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

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.

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Experience Level

Mid Level