Quality Associate Director

Career Category

Job Description

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 illnessesdrives 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. 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.

Quality Associate Director

What you will do

Lets do this! Lets change the world! In this vital role you will serve as Amgens operations enterprise leader for the Supplier Quality Management (SQM) Quality Management System (QMS) processes. Reporting to the Business Performance & Quality Management System Leader you will drive the global SQM strategy lead digital transformation through DQMS and AI-enabled capabilities and ensure consistent compliant and inspection-ready SQM execution across Amgens global operations and affiliate network. You will also shape and govern end-to-end SQM processes ensuring Amgen remains aligned with regulatory expectations and positioned for Quality 2032 ambitions.

As Quality Associate Director Global Process Owner Supplier Quality Management (SQM) you will:

• Provide enterprise leadership governance and decision making for the SQM QMS including global standards end-to-end process design and oversight across Amgen manufacturing sites above site organizations global affiliates and key external partners.

• Drive transformation of SQM capabilities by driving key decisions for Digital QMS (DQMS) initiatives advancing digital tools automation AI and analytics to enhance efficiency maturity and compliance.

• Lead integration of multiple SQM sub-processes including Event Notifications Supplier Corrective Actions and Supplier Change Notifications into one comprehensive streamlined enterprise workflow.

• Oversee the design implementation and sustainment of technical releases that enable continuous evolution of the SQM digital ecosystem and support enterprise inspection readiness.

• Guide cross-functional alignment by partnering with global sites and operations above site functional areas to ensure SQM processes support business needs and regulatory expectations.

• Ensure enterprise inspection readiness for SQM by establishing robust KPIs monitoring systems dashboards and governance mechanisms to predict risks improve issue management and support the high number global audit and inspection engagements annually.

• Lead SQM integration of new sites programs and acquisitions including Rare Disease and future portfolios ensuring seamless adoption harmonization and sustainable SQM capabilities.

• Develop and implement enterprise change management and communication strategies to support adoption of new technologies standards and processes across global functions and supplier partners for the SQM QMS and related processes.

• Represent SQM globally with regulators partners and industry forums to advance standard processes benchmark performance and ensure the QMS remains current with evolving expectations.

• Cultivate a high-performing network of SQM team members providing guidance to senior professionals across multiple departments and sites.

• Directly manage a hard-working team of quality professionals to advance SQM aligned with Quality Strategy for 2032 ambitions.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is a strategic enterprise-minded Quality leader with the following qualifications.

Basic Qualifications:

• Doctorate degree and 3 years of Quality Operations or relevant biopharmaceutical experience OR

• Masters degree and 7 years of Quality Operations or relevant biopharmaceutical experience OR

• Bachelors degree and 9 years of Quality Operations or relevant biopharmaceutical experience OR

• Associates degree and 12 years of Quality Operations or relevant biopharmaceutical experience OR

• High school diploma / GED and 14 years of Quality Operations or relevant biopharmaceutical experience

In addition to meeting at least one of the above requirements you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 10 years of experience in Quality Systems Supplier Quality QMS governance Operations or related GxP functions.

• Experience leading enterprise QMS or digital transformation programs ideally involving automation AI data analytics and advanced digital tools.

• Strong knowledge of global health authority expectations industry standards and procedures for SQM and QMS.

• Track record leading multi-site cross-functional initiatives with strategic impact.

• Demonstrated success in process ownership governance and global standardization.

• Experience supporting inspections and audits with deep understanding of inspection readiness strategies.

• Ability to influence and collaborate with senior leaders external partners and global teams across varying cultures functions and sites.

• Excellent communication skills with the ability to simplify complex quality concepts and gain alignment across diverse participants.

• Strong critical thinking change leadership and problem-solving capabilities in highly matrixed organizations.

• Demonstrated success driving continuous improvement and operational excellence across complex distributed networks.

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 well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts

• A discretionary annual bonus program or for field sales representatives a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

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

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

Salary Range