Executive Director, Product Quality

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.

Executive Director, Product Quality

Live

What you will do

Lets do this. Lets change the world. In this vital role as the Executive Director, Product Quality, you will provide strategic and technical leadership to ensure the highest standards of product quality across multiple late-phase clinical and commercial programs.

This role demands a deep understanding of Amgens Quality systems and commercialization processes, cGMP and international regulatory expectations, as well as the ability to respond to emerging scientific and technical trends that impact the organization.

The successful candidate will manage and mentor team members, lead cross-functional initiatives, and represent Product Quality in cross-functional teams to drive continuous improvement and maintain compliance.

Key Responsibilities

• Manage Directors and additional staff supporting the Product Quality work center teams responsible for deliverables for multiple late-phase clinical or commercial programs

• Advise on CMC strategies and quality risk management for commercialization including strategies for in process controls, specifications, stability, and comparability

• Provide functional and cross-functional review of regulatory CMC submission content

• Serve as a mandatory attendee for Product Quality-related boards and committees like the PQ Review Board

• Directly manage or influence work groups within the Product Quality organization potentially including Process Owners, Quality Assurance specialists, Stability specialists, or statisticians

• Represent Product Quality at Operations Governance meetings

• Lead projects and cross-functional initiatives seeking transformation or continuous improvement in business processes or quality processes

• Collaborate with cross-functional leaders in Quality, Regulatory Affairs, Process Development, Manufacturing, and Supply Chain to resolve issues and advance business imperatives

• Provide strategic, technical, and compliance guidance to cross-functional teams supporting commercialization and lifecycle management of Amgen products and addressing critical investigations

Technical, Leadership and Influence

• Engage with and influence Executive Management, mentor and advise staff

• Serve as decision maker, advisor, and stakeholder using the DAI model

• Proficiency in knowledge of cGMP and international regulatory expectations

• Understanding and responding to the impact of emerging scientific/technical trends and their implications for Amgen

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

• Engage with Amgen colleagues, industry peers, and workgroups to advance Amgen technical CMC perspectives

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.

Basic Qualifications:

• Doctorate Degree & 6 years of Quality, Operations, Scientific or Manufacturing experience, OR

• Master's Degree & 10 years of Quality, Operations, Scientific, or Manufacturing experience, OR

• Bachelor's Degree & 12 years of Quality, Operations, Scientific, or Manufacturing experience, AND

• Six years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Preferred Qualifications:

• Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field

• Expertise in the areas of protein and small molecule analysis and industry regulations

• Ten or more years of pharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience

• Eight or more years working in a regulated environment (direct GMP)

• Five or more years managing staff with increasing responsibilities and larger groups

• Three or more years of experience with authoring or review of regulatory filing or similar regulatory documentation.

• Three or years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances

• Previous experience engaging with regulatory bodies and external organizations

• Knowledge of protein and small molecule quality, compliance and regulatory requirements

• Knowledge of analytical techniques used for protein molecule product quality control

• Understanding of drug substance and drug product development and manufacturing

• Strong leadership and management skills

• General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals

• Previous experience working on a cross-functional team in a matrix environment

They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

Thrive

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 annual base salary range for this opportunity in the U.S. is $267,213 - $310,319.

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:

• 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 and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

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.

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.