Senior Director, Product Quality

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.

Senior Director, Product Quality

What you will do

Let’s do this. Let’s change the world. In this vital role as the leader in 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 Amgen’s 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 advise and mentor team members, lead cross-functional initiatives, and represent Product Quality in cross-functional teams to drive continuous improvement and maintain compliance.

• Advise on CMC strategies and quality risk management for commercialization including strategies for in process controls, specifications, stability, and comparability
• Provide regulatory, strategic, and technical advice to cross-functional teams supporting commercialization and lifecycle management of Amgen products, with scope to include all modalities from pivotal development through commercial
• Collaborate with cross-functional leaders in Quality, Regulatory Affairs, Process Development, Manufacturing, and Supply Chain to resolve issues and advance business imperatives
• Provide functional and cross-functional review of regulatory CMC submission content
• Serve as a mandatory attendee for PQ-related boards and committees like the Product Quality Review Board
• Engage internally and externally with Amgen colleagues, industry peers, health authorities and other external stakeholders to understand emerging regulatory trends, influence policies and inform strategies to advance Amgen CMC imperatives
• Represent Product Quality at Operations Governance meetings
• Lead projects and cross-functional initiatives seeking transformation or continuous improvement in business processes or quality processes
• 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

What we expect of you

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

Basic Qualifications:

• Doctorate degree and 5 years of CMC Regulatory, Quality, Operations, Scientific or Manufacturing experience

Or

• Master's degree and 9years of CMC Regulatory, Quality, Operations, Scientific, or Manufacturing experience

Or

• Bachelor's degree and11 years of CMC Regulatory, Quality, Operations, Scientific, or Manufacturing experience

AND

• In addition to meeting at least one of the above requirements, you must have at least 5 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:

• 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
• Prior experience with a health regulatory authority conducting or overseeing CMC reviews for pharmaceutical products, including experience influencing or implementing agency policies relevant to CMC reviews
• 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

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.

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, including remote and hybrid work arrangements, where possible

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

careers.amgen.com

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.

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.

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.