Amgen - Manager - Quality Assurance

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.

QA Manager

What you will do:

Role Description:

In this role you will be serving patients through internal collaboration with Amgen's global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen's missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients.

The QA Manager will support implementation and management of quality assurance activities at the Amgen Technology and Innovation Center, supporting oversight and maintenance of external suppliers and contract manufacturers. You will be responsible for leading a team of quality professionals who will be maintaining and approving various quality documents including but not limited to: supplier documentation, analytical results investigations, CAPA and audit records. This role will involve collaboration with various Amgen teams to ensure seamless handoffs between teams

Roles & Responsibilities:

- Oversee a team of approx. 6 staff, ensuring their activities and priorities are managed in a compliant and structured manner.

- Ensure team members are appropriately qualified and trained to perform needed activities per company procedures.

- Conduct goal setting, performance reviews, and compensation planning to align with organizational goals.

- Develop, implement, and maintain quality records in compliance with industry standards, GMP practices, and

regulatory requirements.

- Continuously improve processes to enhance efficiency and quality, by applying lean principles and automation.

- Develop, monitor and report metrics to senior management to assess the health of the team's performance.

- Develop solutions that are thorough, practical, and consistent with functional objectives.

- Work cross functionally with various Amgen teams and stakeholders to ensure seamless transition of tasks 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.

- This role may require working in shifts or extended hours within the same shift to support global time zones.

What we expect of you

Basic Qualifications and Experience:

Functional Skills:

Must-Have Skills:

- Working foundation in quality assurance roles and proven team leader.

- Minimum of 6 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.

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.

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.

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