Manager, QA Evening 12 hour Shift (6:00pm-6:00am)

Join Amgens Mission of Serving PatientsAt 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. 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, 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.Manager, Plant QualityWhat You Will DoLets do this. Lets change the world. At Amgen, our mission to serve patients drives everything we do. At our Ohio site, we are building a culture where quality is not just a functionits a mindset. Were seeking a Manager, Quality Assurance who is passionate about leadership, thrives in a dynamic environment, and is ready to make a tangible impact on product quality and patient safety.This is more than a role, its an opportunity to lead from the front, shape quality culture, and ensure we deliver safe, effective therapies to patients worldwide.Lead Quality. Inspire Excellence. Impact Patients.ResponsibilitiesAs a QA Manager, you will lead and elevate quality performance while providing strategic and operational oversight across manufacturing and quality systems. Key responsibilities include:Lead, coach, and developQuality staff across assigned areas and shiftsProvideQA oversight of manufacturing packagingactivities to ensure compliance with cGMP, GDP, and global regulatory requirementsEnsure thatfacilities, equipment, processes, materials, and productsmeet all applicable quality and compliance standardsReview, Approve, And Oversee Key Quality Systems IncludingDeviationsCAPAsChange ControlsValidation documentationProcedures and batch recordsDriveinvestigations and resolution of deviations, ensuring timely, thorough, and compliant outcomesEnsureproduction records and test resultsare accurate, complete, and inspection-readyChampion and leadcontinuous improvement initiativesto strengthen quality systems and operational performancePartner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholdersAssess and managequality risks, escalating critical issues to senior leadership as neededRepresent QA duringinternal and external audits and regulatory inspectionsSupport audit readiness and participate ininspection management activitiesEnsuredocument control excellence, including ownership and timely periodic review of controlled documentsFoster aculture of quality, accountability, and complianceacross all teamsWhat We Expect Of YouWe are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.Basic QualificationsDoctorate degreeORMasters degree and 3 years of quality experienceORBachelors degree and 5 years of quality experienceORAssociates degree and 10 years quality experienceORHigh school diploma / GED and 12 years of quality experienceIn addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced abovePreferred QualificationsBachelors degree in Life Sciences, Engineering, or a related field (advanced degree a plus)3+ years of experience inQuality Assurance within a GMP-regulated environment(biotech/pharma preferred)Priorleadership or people management experiencestrongly preferredDeep knowledge ofcGMP, GDP, and regulatory expectationsProven experience withquality systems(deviations, CAPA, change control, validation)Strong ability tolead in a shift-based operation, with flexibility for evenings, nights, weekends, or holidaysExcellent communication, decision-making, and problem-solving skillsA proactive, collaborative leader who caninfluence and inspire across functionsWhat You Can Expect Of UsAs 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 IncludeA 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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.SponsorshipSponsorship for this role is not guaranteed.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.