In this role, the selected candidate will be responsible for the oversight and the conduct of audits as they relate to Good Clinical Practices (GCP), to ensure compliance with all established regulatory guidelines as well as company policies and procedures.
In this role, the selected candidate will provide quality oversight of Companion Diagnostic (CDx) and Diagnostics development programs at third party diagnostic sites and liaise with Clinical QA/Dev Ops as required in order to ensure the CDx programs meet device regulations and are suitable for use in Pfizer sponsored clinical trials.
In this role, you will manage, coordinate and direct the implementation and operation of metros engineering department quality assurance/quality control (qa/qc) program for all metrolink and other capital projects.
The candidate will also play a supporting role in Crowes tax publications. A successful candidate will be prepared to assist the current leadership in expanding revenue by working with practice offices on existing clients and external opportunities
In this role, you will be responsible to provide leadership and participate in lot release, change control review and approval, manufacturing support, record approvals, investigations approval, lab testing changes and project support within the quality organization.
The Quality Assurance Drug Product Manager / TL will be primarily based in Sterile Product Manufacturing building (SPM) and the Sterile Product Support (SPS) building and will provide general oversight to MQA personnel and Floor QA personnel.