• Responsible for management of staff, procedures, and systems that apply to analytical and bioanalytical activities located in Katzrin, Israel.
• Maintain approved QC controlled documents files and assist in the distribution of documents for Controlled Document Binders in Production, QC and other departments.
• Ensure documentation support GLP/GMP and regulatory efforts.
• Coordination and management of procedures and documentation supporting drug substance, drug product, and clinical formulation stability studies.
• Oversee the bioanalytical measurement of drug and metabolites in biological samples to support pre-clinical and clinical stidies.
• Assignment of individual staff and project teams based on operational needs, available resources, forecasts, budget, etc.
• Establish and maintain a state of ‘readiness’ in preparation for inspection, audit, due diligence, visitation, with regard to compliance and safety.
• Audit and/or approve all data and documentation generated by the laboratories, ensuring the integrity, compliance, and ethics of the laboratory operations.
• Collaborate with Metrology and Information Technology to develop and maintain preventive maintenance and calibration (IQ/OQ) programs to support the compliance of analytical software and hardware relative to CFR21, and FDA guidelines.
• Write, review, and approve protocols, analytical methods, and SOPs impacting the various laboratory activities.
• Track and evaluate the performance of employees, analytical systems and compliance systems.
• Train QC personnel on all aspects relevant regulations (FDA, GMP, GLP, ICH, USP), on analytical techniques and technology. Submit regular updates and status reports to upper management.
• Act as a strong liaison between USA and Israel to ensure smooth and robust method and technology transfer.
• Ensure the safekeeping and inventory of GMP, GLP, Quarantine, and clinical material by continuously improving, and establishing new controls.
• Guide and interact with third party laboratories and manufacturers to ensure compliance with SG operations.
Salzman Group Ltd. is an Israeli biotechnology firm focused on the discovery and development of transformative pharmaceuticals. We are seeking a Director of Quality Control to manage our analytical and bioanalytical laboratory in Katzrin, Golan Heights, Israel.
