Manager, Product Quality- US Remote

Amgen; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading biotechnology company is seeking a Manager for Product Quality to oversee cross-functional quality support in the U.S. This role involves engaging with various departments for product filings and regulatory submissions. Candidates should possess a Doctorate or relevant Master's, Bachelor's, or Associate's degree, along with experience in quality assurance and regulatory compliance. This position offers a competitive salary and flexible work arrangements.

Benefits

Comprehensive employee benefits

Flexible work models

Stock-based long-term incentives

Discretionary annual bonus program

Qualifications

• Experience with biologic products in a regulated environment.
• Ability to develop patient-oriented strategies accounting for business needs.
• Experience authoring or reviewing regulatory documentation.

Responsibilities

• Engage with Product Quality and Regulatory departments.
• Provide cross-functional quality support for product programs.
• Manage product quality-related activities including GMP documentation.

Skills

Pharmaceutical Quality Assurance

Project Management

Regulatory Documentation

Cross-functional Collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Overview

Join to apply for the Manager, Product Quality- US Remote role at Amgen

Join Amgen’s Mission of Serving Patients
Their shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, Amgen has helped pioneer biotech in the fight against the world’s toughest diseases, focusing on Oncology, Inflammation, General Medicine, and Rare Disease. 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 lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What You Will Do

Let’s do this. Let’s change the world. In this vital role you will engage with Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on a variety of activities. Such activities include product filings, program improvements, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.

• Provide effective, cross-functional quality support for program results for late phase and commercial programs, including actions required for the annual product reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author PQ-owned regulatory filing sections and RTQs
• Support 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.
• Project management of select aspects of Product Quality or broader Product Lifecycle Quality
• Direct responsibility for Product Quality related activities including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems and product data management including comparability assessments, annual product reviews, and product quality risk assessments. Contributions will aim to improve initiatives to ensure overall product health.

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 an individual with these qualifications.

Basic Qualifications

• Doctorate degree
• Or Master’s degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience
• Or Bachelor’s degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience
• Or Associate’s degree and 8 years of Quality, Operations, Scientific, or Manufacturing experience
• Or High school diploma / GED and 10 years of Quality, Operations, Scientific, or Manufacturing experience

Preferred Qualifications

• B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
• 4+ years working in a regulated environment (either direct GMP or technical support) with experience working with biologic products
• 1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation

What you can expect from 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 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.

Application deadline: Amgen anticipates accepting applications until 10/1/2025; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

Amgen is an Equal Opportunity employer and will consider all qualified applicants 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. Please contact us to request accommodation.

We will not penalize for redacting age-identifying information in materials submitted as part of the application process.

Job Details

• Seniority level: Not Applicable
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Biotechnology Research and Pharmaceutical Manufacturing

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