The Director of Quality Assurance (RN) will be responsible for leading the development, implementation, and direction of effective quality strategies with oversight for all of quality activities and improvement within the organization.
This position is responsible for setting up the sites Quality Strategy and Quality Management System as well as oversee the Quality Assurance, Compliance, Regulatory, Quality Engineering and Continuous Improvement groups.
In this role, the selected candidate will be provide strategic direction and leadership to the Clinical Operations including RN Managers & Quality Management teams; oversee operational efficiency and quality services at clinical sites.
The QA Director will be responsible for implementing and ensuring agile quality standards and methodologies for all testing initiatives. Builds, manages, and directs a testing team of Test Engineers to deliver all software quality assurance and testing solutions.
In this role, the selected candidate will be responsible for ensuring appropriate stability guidance is provided for all new biologic programs at the Formal Stability Study stage to develop a solid stability package for filing worldwide.
In this role, you will collaborate with quality leadership and other key stakeholders to formulate and establish policies, operating procedures, and goals in compliance with internal and external guidelines.
This positions provides leadership and direction through associate directors, managers or professional staff. Directs the development, planning, implementation and maintenance of the Compliance processes and operations for the site including new or existing products and/or technologies.
The Director of Quality will wear multiple hats and oversee all of the Quality and Regulatory responsibilities. This position will start off as an independent contributor position but with the opportunity to build out a Quality team and bring the department up to where the organization needs it to be.
In this role, the selected candidate will be responsible for understanding current and future customer needs and approving customer requirements (Strategic) from a BU perspective and develop systems and processes to meet or exceed customer requirements.
In this role, you will be responsible for
provide innovative direction and guidance on reports, communications, and training materials and ensure recommendations are aligned with customer - organization needs and capabilities.
In this role, you will have proven ability to lead a diverse team, excellent communication skills, including the ability to work well with people at all levels and strong organizational, analytical, problem solving, and management skills.
This position will be responsible for ensuring appropriate stability guidance is provided for all new biologic programs at the Formal Stability Study stage to develop a solid stability package for filing worldwide.