Principal Product Quality Leader

1001 Amgen Inc.; Thousand Oaks (CA); Hybrid; USD 139.000 - 188.000; Vollzeit

Benefits dieser Stelle

Retirement plan

Medical/dental/vision coverage

Stock-based incentives

Flexible work models

Zusammenfassung

Amgen in Thousand Oaks, CA is recruiting a Principal Product Quality Leader to provide technical leadership across Product Quality, Regulatory, and Manufacturing teams. You will own GMP-related activities and author/review regulatory filings, with responsibility for one or more late-stage or commercial biologics programs.

You will engage with cross-functional teams on product filings, investigations, change controls, and product quality risk assessments, helping to develop, implement, and manage

Qualifikationen

• Doctorate or master's or bachelor's with relevant QA/Operations/manufacturing experience.
• Experience in regulated environments and biologics is preferred.
• Experience authoring or reviewing regulatory documents.

Aufgaben

• Provide cross-functional quality leadership for late phase and commercial programs.
• Develop strategies and perform risk-based evaluation of complex quality data.

Kenntnisse

Oral communication

Written communication

cGMP knowledge

Regulatory knowledge

Data management

Ausbildung

Doctorate degree / 2 years QA/Operations

Master's degree / 4 years QA/Operations

Bachelor's degree / 6 years QA/Operations

Associate's degree / 10 years QA/Operations

High School Diploma / 12 years QA/Operations

Jobbeschreibung

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

Principal Product Quality Leader

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 Principal Product Quality Leader. As Principal Product Quality Leader, 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. You will support one or more of Amgen's late-stage or commercial biologics products and provide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategies to meet the Product Development Team goals. You will be directly responsible 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

• Provide effective, cross-functional quality leadership, 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
• 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

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 dedicated professional we seek is a collaborative partner with these qualifications.

Basic Qualifications

• Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience OR Master’s degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience OR Bachelor’s degree & 6 years of Quality, Operations, Scientific, or Manufacturing experience OR Associate's degree and 10 years of Quality, Operations, Scientific or Manufacturing experience OR High School Diploma/GED and 12 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

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

Benefits and Perks

• 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

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 Sponsorship for this role is not guaranteed.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range

138,639.25USD -187,570.75 USD

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.

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