Major Deviation Owner

Location: Thousand Oaks
Posted on: June 23, 2025

Job Description:

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Major Deviation Owner What you will do Lets do this. Lets change the world. In this vital role you will investigate deviations in the Amgen Thousand Oaks Manufacturing Clinical Supply Organization, including Drug Substance and Drug Product manufacturing, Supply Chain, Drug Product Assembly/Packaging, Quality Control, and Warehouse Operations. These investigations are aligned with regulatory requirements and include determination of scope, product impact, root cause, and effective corrective/preventative actions (CAPAs). This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing, Quality Assurance, Process Engineering, Process Development, Analytical Sciences, Quality Sciences, Quality Control, Supply Chain, and Regulatory Affairs. Responsibilities: Manage deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings. Drive improvements to the investigation process Defend investigations to regulatory inspectors and internal auditors Present complex topics clearly to large and small groups at all levels in the company Build effective relationships across functions Clear and concise technical writing What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications. Basic Qualifications: Doctorate degree Or Masters degree and 2 years of manufacturing experience Or Bachelors degree and 4 years of manufacturing experience Or Associates degree and 8 years of manufacturing experience Or High school diploma / GED and 10 years of manufacturing experience Preferred Qualifications: 5 years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility Degree in Science or Engineering Experience leading complex investigations Demonstrated project management ability Excellent written and verbal communication skills Ability to work in a team matrix environment and build relationships with partners 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, well 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 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, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. 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. 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. 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.

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