In this role, the selected candidate will ensure that we can maintain 24/7 operations with no downtime to due quality issues, making sure the systems are operating properly and consistently, covering all testing needs.
This position will serve as a leader for Pharmacovigilance quality of all post marketing and clinical PV activities and sources in accordance with international GPvP requirements, company procedures and industry best practices.
Responsible for leadership of QC functional areas that include: Chemistry (protein chemistry, immunochemistry), Sample Management, Data Management and Stability as well as oversight of Contract testing services used by Alexion in support of GMP Operations.
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.
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.
The QC Microbiology, Associate Director oversees a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting and overseeing testing, trending, continuous improvement, and reporting of results.
In this role, the individual will be responsible for providing overall direction for all quality assurance related activities associated with the China expansion project, including the following Quality workstreams; Quality Assurance, Qualification/Validation, Documentation, and
The Sr. Director designs and builds a comprehensive data program as a key leader in the business and partnering with IT on mapping the architecture, creates practices for data governance, ensures accessibility, creates standardization and ownership.