Center Quality Manager

Job Title:

Center Quality Manager

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands‑on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics.

We currently have an exciting opportunity available for a Manager, Center Quality in Hammond, LA!

Position Summary

To assist in the development of policies, procedures, and processes to ensure the necessary requirements and controls are appropriately addressed to reduce or eliminate the potential of errors. This may be identified through scheduled audits, performance observations, or record review.

• Assures the Donor Center(s) complies with all applicable state, federal, and European Union guidelines.
• Direct responsibility for the day‑to‑day activities, evaluation, and training of the Quality Assurance Specialist.
• Authorizes the release of final product and has the authority to stop shipment of any product that does not meet compliance or customer specifications.
• Assures accurate labeling and documentation of shipments.
• Assures center maintains state of readiness for regulatory and customer audits.
• Responsible for tracking and trending errors, corrective actions, and the approval of preventative action.
• Reports compliance status to Center Management and Regional Manager, Quality Assurance routinely.

Competencies

Maintaining Objectivity

Written and oral communication skills

Outstanding interpersonal, verbal, and written communication skills - must be able to translate technical concepts into non‑technical terms for both senior level management and frontline staff

Strong organizational, interpersonal and collaborative skills

Use independent judgment to assess compliance with regulatory requirements and SOPs

Develop data systems and ETL pipelines to provide data outputs that meet business needs and objectives

Develops, implements, and maintains Key Performance Indicator reports for organization, including all donor sites

Develops targeted data extraction within report template(s) to assist departmental needs

Identifies resourceful solutions to enhance the electronic systems

Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures

Must have excellent writing and oral skills

Must have thorough knowledge of Oracle, SQL, and Jaspersoft studios

Must be able to prepare, deliver spreadsheets, data analysis, presentations and facilitate for small and large groups

Excellent problem‑solving and analytical skills and be able to frame issues clearly for less technical colleagues and customers

Must be able to read, understand, and implement programs based on technical regulations and manuals

Must have a strong customer service orientation and able to work well under pressure while interfacing with all levels of personnel, and consultants

Ability to train and motivate employees at all levels within an organization Knowledge of all Federal and State regulations including OSHA and CUA

Must be project oriented, creative, and computer literate

Advanced knowledge of standard office software (Microsoft Office including Word, Excel, and Microsoft Project)

Good mechanical aptitude and knowledge of general maintenance

Individual must have the knowledge and experience to operate and maintain the facility and production systems, and associated equipment: high…