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).
Develop plans, schedules, and budgets and identify resources required on assigned programs or projects. Identify risk areas and develop contingency plans to eliminate or mitigate risk that could result in schedule delays or failure to meet technical specification or schedule requirements.
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.
In this role, the selected candidate will
oversee the maintenance of clinical records and files to comply with Conditions of Participation (COPs), using measurements, as licensure, certification, and accreditation results.
This role will specifically include evaluation of portfolio processes and change management activities across the Bank while offering guidance on where and how improvements can be made, including recommendations on key controls, performance metrics, and governance needs for monitoring the change management capability.
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.
Participate in providing effective and efficient IT services which meet the needs of client hospital;support account profitability which meets revenue and margin requirements set at the corporate level.