Product Quality Associate Director

Amgen Inc. (IR); Northern (KY); Hybrid; USD 145,000 - 197,000; Full time

Benefits offered by this job

Competitive benefits

Total Rewards Plan

Stock-based incentives

Job summary

Amgen’s Product Quality team seeks a highly motivated Product Quality Associate Director to provide technical leadership across product quality activities for late-stage or commercial biologics. You will collaborate with Regulatory, IQD, Process Development, QA and other functions on filings, investigations, and regulatory submissions.

The role emphasizes ownership of GMP documentation, product quality risk assessments, and development of strategies to meet Product Delivery Team goals.

Qualifications

• Demonstrate proficiency in oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies.
• Demonstrate proficiency in knowledge of cGMP and international regulatory expectations.
• Strong scientific data management and organization skills with attention to detail.

Responsibilities

• Ensures Product Quality deliverables are appropriately defined within timelines across the Product Delivery Team.
• Coordinates discussion and leads decision making for strategies and activities within the Product Quality Team for programs they support.
• Accomplishes results by leading activities across the product quality team and with cross-functional SMEs for programs they support.
• Provide effective, cross-functional Quality leadership, and influence and support program deliverables for late phase and commercial programs.
• Provide subject matter expertise and strategic influence for science and risk-based evaluation of complex process and product quality data.

Skills

Oral and written communication

cGMP knowledge

Quality data management

Cross-functional leadership

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate’s degree

High school diploma

Job description

Career Category Quality 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Product Quality Associate Director

What you will do

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

Amgen’s corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Product Quality Associate Director. As Product Quality Associate Director, you will provide technical expertise and leadership within a Product Quality Team. 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. In this role you will serve as the accountable Product Quality Leader, representing Quality on the Product Delivery Team(s) for one or more of Amgen's late-stage or commercial biologics products and provide subject matter expertise to the Product Quality Team(s) to develop, implement, and manage strategies to meet the Product Delivery Team goals. You will provide key input and strategic influence 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. Your contributions will significantly improve initiatives intended to ensure the overall product health.

Primary Responsibilities include the following:

• Ensures Product Quality deliverables are appropriately defined within timelines across the Product Delivery Team. Deliverables are clear with priorities set based on program guidance.
• Coordinates discussion and leads decision making for strategies and activities supported within the Product Quality Team (Quality Assurance, Stability, Process Development, and other functions as needed) for programs they support.
• Accomplishes results by leading activities across the product quality team and with cross-functional SMEs for programs they support.
• Provide effective, cross-functional Quality leadership, and influence and support program deliverables 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
• Provide subject matter expertise and strategic influence for 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

Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.

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 and 3 years of Quality, Operations, Scientific, or Manufacturing experience
• Master’s degree and 5 years of Quality, Operations, Scientific, or Manufacturing experience
• Bachelor’s degree and 7 years of Quality, Operations, Scientific, or Manufacturing experience
• Associate’s degree and 12 years of Quality, Operations, Scientific, or Manufacturing experience
• High school diploma / GED and 14 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
• 6+ 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

Functional Skills:

Must-Have Skills:

• Demonstrate proficiency in oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
• Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
• Strong scientific data management and organization skills with attention to detail

Soft Skills:

• Analytical and problem-solving skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines
• Team-oriented, with a focus on achieving team goals

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.

Benefits

• 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.

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.

Equal Opportunity Statement

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

145,241.20USD -196,502.80 USD

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen