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VP Quality, Product Quality & Sciences

Company: Amgen Inc. (IR)
Location: Thousand Oaks
Posted on: January 15, 2022

Job Description:

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission-to serve patients-has driven our status as one of the world's preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses. Live What you will do Let's do this. Let's change the world. In this vital role you will be a key member of the Quality Leadership Team. Amgen is a seeking a VP Quality, Product Quality and Sciences. In this role, this innovative leader is responsible for providing leadership and strategic direction and Quality support for Process Development through leadership of the Product Quality and Quality Sciences organizations. This position can be located in Thousand Oaks, CA or Cambridge, MA and reports to the Sr. Vice President of Quality and is a member of the Quality Leadership Team. Responsibilities Product Quality (PQ) - Specifications, Stability, Comparability, Annual Product Review Quality Sciences - Inspection Prep., Deviation/complaint review; Reportability Ensures product quality standards are met and in compliance with applicable regulatory requirements and specifications Ensures that compliance-related issues internally or externally are managed in accordance with regulatory agency requirements and expectations Partner with process development and regulatory counterparts to ensure successful development of regulatory submissions and setting of specifications - Provides product quality input to Chemistry, Manufacturing and Controls (CMC) strategy As a Vice President and key member of the Quality Leadership team, participates in provides input into the various strategy, governance and talent forums Alerts senior management of significant quality, compliance, supply and safety risks Reviews draft biologics license application (BLA) input from a Product Quality perspective Ensures root cause investigations of complex technical topics are effective Supports manufacturing investigations and regulatory submissions Represents areas of responsibility and provides leadership on Quality Leadership Team and Site Senior Management teams Participates as decision maker in key governance forums, such as the Product Quality Management Review and others Partner with clinical manufacturing in establishing process standards to support process transfer As part of the leadership team, participates in the company's global strategy as it relates to product quality Coaches and develops Quality leadership and ensures further advancement of the Best Place for Talent methodologies Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Vice President Quality we seek is a leader with these qualifications. Basic Qualifications Doctorate degree & 8 years of quality experience OR Master's degree & 10 years of quality experience OR Bachelor's degree & 12 years of quality experience AND 8 years of direct managerial experience. Previous experience managing other managers Preferred Qualifications Possess management experience with demonstrated experience in microbial and mammalian testing and production Experience in process characterization and process validation of a biologic Experience in regulatory submissions as it pertains to Chemistry, Manufacturing and Controls (CMC) Experience working for a regulatory agency Ability to interact with Regulators worldwide Involvement in Industry trade associations such as PDA, IQ Consortium, CASSS, or PhRMA Experience working with standard setting Organizations e.g. PIC/S, USP, BP, Pharm. Eur Ability to lead multiple strategic imperative simultaneously Ability to lead and operate in a matrixed or team environment Ability to travel to domestic and international Amgen sites What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen focuses on areas of high unmet medical need and uses its 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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. Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.. 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.

Keywords: Amgen Inc. (IR), Thousand Oaks , VP Quality, Product Quality & Sciences, Executive , Thousand Oaks, California

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