Director, Quality Assurance - Holly Springs, NC

Director, Quality Assurance

Let'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.