Product Quality Director

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Product Quality Director

What you will do

Lets do this. Lets change the world. In this vital role you will be the champion for a product team as the Product Quality Leader (referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization. The PQL has responsibility for working with PQ staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional areas on the resolution of issues associated with process/manufacturing, in process controls, analytical methods, specifications, comparability, stability, reference standards, importation testing, investigations, change control, regulatory submissions and inspections.

The PQL has responsibility for inspiring change to implement operationally efficient processes and corporate alignment across international sites. As a leader in Product Quality, the successful candidate is expected to have experience, knowledge and understanding of large molecule development and commercial lifecycle maintenance, product stability programs, regulatory filings, risk assessment, and Amgen Quality Management Systems.

Amgen offers the opportunity to be at the interface between research, global development, and manufacturing to ensure that our molecules become medicines. Many of the technologies were employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.

This role is directly responsible for the product quality and related activities (e.g., comparability, specifications, stability, annual product review) in support of the Product Development Team (PDT). The PQL provides scientific oversight for the product quality of pivotal and/or commercial product(s) including timely product data review, ownership of GMP documents and regulatory filing sections, execution of transactions in relevant GMP system (EDMQ, change control, etc), and support for regulatory audits and responses to questions.

The individual is directly responsible to lead a Product Quality Team (PQT), including oversight of the product stability programs, and providing indirect staff management and guidance to members of the PQT.

Key Responsibilities include:

• Provide effective, cross-functional quality leadership, and manage multiple, complex long- term PDT deliverables for late phase and commercial programs, including actions required for the PQT/APR; specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and PQ owned regulatory filing sections and RTQs

• Provide expertise in science and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues

• Demonstrate proficiency in oral and written communication of complex information to Amgen leadership, peers and regulatory agencies including communications associated with inspectional activities

• Demonstrate proficiency in knowledge of cGMP and international regulatory expectations

• Understand and respond to the impact of emerging scientific/technical trends and their implications for Amgen

• Actively mentor new and existing team members to develop Product Quality core skills

What we…