Product Quality Associate Director

Amgen•Denver, PR

22h•$145,241 - $196,503

About The Position

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 pioneered 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.

Requirements

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

Nice To Haves

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

Responsibilities

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

Benefits

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

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