SR AD, Quality Control

Description

Duties & Responsibilities

• Direct, lead, develop the Quality Control staff in oversight of the purity, potency and safety testing to ensure high quality bacterial and viral products. Administer and Drive company policies and safety program. Make hiring and discipline recommendations in accordance with policies and procedures. Develops and institutes quality efficiency improvements within areas of QC testing and analysis. Ensures QC workforce develops and maintains a positive, synergistic relationship with other operating departments and external stakeholders.
• Responsible for compliance with industry guidelines and governmental regulations, preparing, auditing, and reviewing test methods, test records and other GMP
• documentation, hosting inspections and audits of the QC areas. Establishes and maintains quality agreements with vendors, third-party manufacturers, and contractors.
• Evaluate and provide leadership support for annual expense and capital budgets for departments and monitor to stay within prescribed limits. Complete annual reviews of all production outlines, special outlines, etc.
• Leads the oversite of all testing of raw materials, in-process samples containers/closures, packaging materials, toll/contract manufactured products and BI vaccine manufactured products. Determines technical adequacy of the scientific documents and testing methods used within various Quality Control departments. Leads the oversite of test Master References and reagents that are developed internally and ensure compliance with Validation and Qualification of Quality Control assays.
• Directs administration of the BI biological stability program including evaluation of trends/testing at appropriate intervals. Participating in the review of design, manufacturing, purchasing, and test documentation to ensure that the company´s and customers´ quality requirements are met on products, programs, areas, and functions.
• Directs the oversight of data integrity with instrumentation and manual processes used throughout the Quality Control laboratories.
• Leads in coordinating the transfer of new products and technologies into QC. Support of site transfers through leadership and direction ensuring robust processes and compliance.
• Responsible for compliance with industry guidelines and governmental regulations, preparing, auditing, and reviewing method test records and other GMP
• documentation, hosting inspections and audits of the QC areas. Establishes and maintains quality agreements with vendors, third-party manufacturers, and contractors.
• Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH´s excellent reputation in the community.

Requirements

• Bachelor´s degree from an accredited institution in microbiology, chemistry or related scientific area and a minimum of ten (10) years relevant industry experience in a GMP biological vaccine and/or pharmaceutical production environment.
• Masters degree and/or PHD is strongly preferred.
• Experience must be inclusive of a minimum of five (5) years in a laboratory management environment leading a substantial number of employees
• Excellent reading / writing and communication skills.

Desired Skills, Experience and Abilities