Director, Quality Assurance

Career CategoryQualityJob DescriptionJoin 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.DIRECTOR, QUALITY ASSURANCEWhat you will doLet’s do this. Let’s change the world. In this vital role you will be accountable for leading the quality team supporting drug substance manufacturing execution activities within our site’s second FleX Batch manufacturing facility.As a QA Director, you will build and lead a high-performing quality organization responsible for supporting 24/7 manufacturing operations and will contribute to the development of the site Quality strategy leading teams accountable for all aspects of quality oversight of GMP systems and operations, while fostering a culture of execution excellence, accountability, and continuous improvement.Provide Quality input and expertise to support project and operational design decisions.Lead operational readiness activities to implement quality systems, programs, business processes and procedures.  Track progress and communicate status.Lead and participate in Quality Risk Assessments.Build organization according to hiring strategy that supports project milestones. Recruit, coach, develop, motivate, and retain staff. Ensure ongoing organizational structure capable of adapting to evolving business needs.Drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies.Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties.Represent ANC Quality in cross-function and cross-site forums and in collaborations with Quality leaders across the Amgen network.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 professional we seek is a person with these qualifications.Basic Qualifications:Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering experience ORMaster’s degree and 8 years of Quality/Manufacturing/Engineering experience ORDoctorate degree and 4 years of Quality/Manufacturing/Engineering experienceIn addition to meeting at least one of the above requirements, you must have at least 4 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:Bachelor’s Degree in a Science field15+ years of experience in Quality within the biopharmaceutical or regulated manufacturing industryPrevious experience in Quality oversight of Biologics drug substance operationsStrong knowledge of cGMPs and experience interacting with RegulatorsAble to drive process improvement within area of responsibilityAble to successfully manage workload to timelinesProven experience supporting regulatory inspections and site auditsDemonstrated leadership of cross-functional teams within a manufacturing siteExperience driving operational excellence and continuous improvement initiativesExcellent communication, leadership, and influencing skillsCompetencies:Strategic Thinking (Site Execution Focus)Regulatory & Compliance ExpertiseOperational ExcellenceLeadership & Team DevelopmentChange ManagementData-Driven Decision MakingWhat 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