Oversees all requests for procedural documents related to health authority inspections and internal audits. Provides local coverage for responding to urgent requests in a timely manner, retrieving procedural documents from the EDMS. Performs technical review of procedural documents, ensuring use of appropriate templates and formatting.
In this role, the selected candidate will perform all technical final financial statement review in addition to performing a variety of functions including audits, tax verses book adjustments, etc for a diverse group of private clients.
The Quality Manager will be responsible for leading the Site Quality organization to drive best in class performance and drive a positive Quality and continuous improvement culture to effectively manage quality cost.
Provide documentation review/approvals supporting external and internal teams to provide a high degree of assurance that sterile drug product programs will achieve regulatory approval, clinical release, and commercialization.
The ideal candidate will perform a variety of functions including performing audits, financial statement prep and technical review, tax verses book adjustments, etc for a diverse group of private clients, primarily in real estate.
Responsible for new or changes in regulations on specifications, procedures, quality, and supply plans both domestic and international, and implications where utilized in a range of finished product (examples; GMO, ingredients from China).
The QA Manager is responsible for the quality management of vendors and contractors to ensure regulatory compliance of manufacturing, testing, packaging, and release activities of Contract Manufacturing Organizations (CMO's).
Engage with the Group's senior management oversight team, develop strong working relationships with all business lines across Supervision, and interpret and implement various quality management guidelines as outlined by the Board of Governors.
The role also contributes to future definition of the Product Security Policies and Procedures across BD and any business unit specification while supporting tactics required to achieve Product Security objectives across business units and functions.