Quality Compliance External Affairs, Senior Specialist Quality

Career Category

Job Description

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.

Quality Compliance External Affairs, Senior Specialist Quality

What you will do

Let’s do this. Let’s change the world.

Pharmacopeial Program Management

• Lead project management of major global pharmacopoeias (USP, Ph. Eur., JP, ChP), ensuring structured review and implementation of periodic updates.

• Coordinate cross-functional teams and site points of contact at global manufacturing sites to execute required changes in alignment with compliance timelines.

• Ensure all pharmacopeial changes are appropriately assessed, documented, tracked, and maintained in a current state within Amgen systems.

• Author compendial assessments within Amgen’s documentation management systems for audit readiness purposes.

Regulatory Intelligence & Industry Engagement

• Proactively monitor early signals, emerging trends, and evolving regulatory issues impacting global operations as it relates to pharmacopoeia matters.

• Represent Amgen’s approved positions in external organizations and trade associations as assigned, to influence and shape pharmacopeial public standards.

• Liaise with regulators through industry associations, supporting advocacy and alignment efforts.

Cross-Functional Collaboration

• Partner with internal SMEs to ensure scientific alignment on pharmacopeial developments and regulatory changes.

• Support knowledge-sharing across functions to enhance understanding of external landscape developments.

• Provide back-up support within External Affairs as needed to ensure business continuity.

• Networking across various Amgen functions including Quality Control, Quality Assurance, Process Development/Attribute Sciences, Material Quality, Engineering, Product Quality, Microbiology, Toxicology, GRAAS-CMC and R&D Policy. Liaise with Governmental Affairs, Supply Chain, manufacturing / development sites, External Quality (CMO) and affiliates/IDQ, as appropriate

• Networking with peers from other companies (e.g., at conferences or while representing Amgen’s interests in industry associations) and regulators as appropriate.

Continuous Improvement & Operational Excellence

• Lead and contribute to continuous improvement initiatives to enhance efficiency and effectiveness of the pharmacopeial program.

• Collaborate with SMEs and system owners to optimize databases, tracking tools, and internal processes.

• Support additional projects aligned with departmental priorities and professional development opportunities.

Travel

• Travel domestically and internationally as required (approximately up to 10%).

What we expect of you

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

Basic Qualifications:

Doctorate degree and 2 years of quality compliance experience OR

Master’s degree and 4 years of quality compliance experience OR

Bachelor’s degree and 6 years of quality compliance experience OR

Associate’s degree and 10 years of quality compliance experience OR

High school diploma / GED and 12 years of quality compliance experience

Preferred Qualifications

• Background in Quality, QC, QA, Engineering desirable.

• Understand quality documentation and laboratory practices including general methodologies, specifications and product quality standards.

• Excellent communication skills for both internal conversations and when representing Amgen at external forums

• Conflict resolution

• Teamwork and Networking

• Good organization, planning and prioritization capability

• Time management

• Attention to details

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 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.

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.

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