Quality Assurance Manager

Join Amgen's Mission of Serving PatientsAt 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. 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.Senior Manager QAWhat you will do Let's do this. Let's 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 function—it's a mindset. We're seeking a Senior 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, it's an opportunity to lead from the front, shape quality culture, and ensure we deliver safe, effective therapies to patients worldwide.Responsibilities:Lead, coach and develop the QA team, responsible for quality oversight of Incoming Quality, Warehouse Operations, Distribution and Facility and Engineering. Team scope includes disposition of product, materials and components, including on-the-floor support, record review, quality oversight of deviation investigations and changes, document approval.Ensure AOH product is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and applicable regulations.Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes.Lead and participate in Quality Risk Assessments.Provide Quality input to support project or operational design decisions.Build organization according to hiring strategy that supports our growth. Partner with HR to recruit, coach, develop, motivate, and retain staff. Ensure ongoing organizational structure capable of adapting to evolving business needs.Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards.Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies.Develop strategies in support of regulatory inspections and site audits.Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties.Develop area budget, manage expenditure and identify productivity improvement opportunities.Represent AOH Quality in cross-function and cross-site forums.Alert management of significant quality, compliance, supply, and safety risks.Communicate across all levels of the organization. Facilitate development of solutions to critical business issues.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a leader with these qualifications.Basic Qualifications:Doctorate degree and 2 years of Quality/Manufacturing/Engineering experienceOrMaster's degree and 6 years of Quality/Manufacturing/Engineering experienceOrBachelor's degree and 8 years of Quality/Manufacturing/Engineering experienceOrAssociate's degree and 10 years of Quality/Manufacturing/Engineering experienceOrHigh school diploma / GED and 12 years of quality/Manufacturing/Engineering experienceIn addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced abovePreferred Qualifications:Master or Bachelor's Degree in a Life Science field5 + years' pharmaceutical industry experiencePrevious experience in Quality oversightStrong knowledge of cGMPs and experience interacting with RegulatorsProven experience with quality systems (deviations, CAPA, change control, validation)Able to drive process improvement within area of responsibilityAble to successfully manage workload to timelines, decision-making, and problem-solving skillsLeadership and communication skills. A proactive, collaborative leader who can influence and inspire across functions.What 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, we'll 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 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.