This position is responsible for the regulatory compliance of the plasma center organization. It acts the designated company authorized official for all communications with regulatory agencies regarding Plasma related issues. The position provides advice and direction regarding regulatory requirements. It is responsible for preparing and making submissions to regulatory agencies.
Other duties include:
Provide leadership and support to Plasma Operations, Center Management, and Plasma Corporate staff to ensure regulatory compliance by Center facilities and Plasma organization.
Review and interpret all applicable regulations governing Plasma processes and procedures to ensure full compliance.
Ensure Plasma Centers are in compliance with all governing agencies through inspections, reporting and follow-up of issues; recommend corrective and preventive actions as necessary.
Is available to regulatory authorities during inspections to ensure appropriate information is supplied as requested. Accompanies FDA inspectors for pre-scheduled new center audits.
Prepare submission of Biologics License Applications (BLA’s) associated to center establishments and plasma products and CLIA/COLA licensing as related to Plasma Center operations.
Prepare FDA Annual Report as it relates to the Plasma organization.
Assist Plasma QA and Operations in the crafting audit and inspection responses.
Provide consultation regarding Lookback, Post-Donation and Error/Accident, and BPDR situations as requested.
Initiate Recalls and follow-up with the FDA, other applicable regulatory agencies and customers as required.
Responsible for review and approval of new and revised Plasma Center Standard Operating Procedures (SOP’s); review applicable training materials with regard to all applicable regulations to ensure compliance.
Interface with Plasma Operations Management, Plasma QA, Medical Director and other departments; make regulatory decisions and recommendations as applicable and required.
Supervise departmental operations, developing staff, assigning and reviewing projects and tasks.
Maintain current knowledge of regulations.
Serve as representative and advisor to Plasma management concerning regulatory requirements and their impact on processes. and procedures.
Bachelor’s degree in Biological Sciences or related health sciences; Master’s degree desirable; degree can be offset by equivalent experience. Progressively more responsible experience of 7-10 years in Plasma industry or related field or FDA regulated industry with some laboratory and GMP experience. Strong technical background. Knowledge of U.S. and other regulations (FDA, GHA, EMA, cGMP, OSHA, CLIA, etc.), industry initiatives (IQPP), and Plasma Center SOPs. Ability to handle heavy workloads, manage multiple and concurrent projects, and make quick and accurate decisions utilizing good judgment. Ability to prioritize; professional manner; strong written and oral communication skills; effective delegation skills. Customer service oriented; team player disposition. Ability to use personal computer and software including office applications. Able to understand and develop budgets.
About ADMA BioCenters
ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases.