Block Head Manager

Role & responsibilities

The Block Head oversees all manufacturing, production, and operational activities within a specific manufacturing block specializing in controlled substances, including ketamine formulations. The role is responsible for ensuring efficient and compliant production, maintaining the highest quality and safety standards, and meeting all regulatory requirements set by agencies such as the FDA and DEA.

Responsibilities

Production and operations management:

• Manage day-to-day production activities to achieve output targets and schedules for ketamine products.
• Optimize manufacturing processes to improve efficiency, reduce waste, and manage the departmental operating budget effectively.
• Plan and supervise the manufacturing of batches in strict adherence to validated processes and standard operating procedures (SOPs).
• Coordinate with cross-functional teams, including Supply Chain, Quality Assurance, and Engineering, to ensure seamless operations.

Quality and compliance:

• Ensure rigorous compliance with Current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and other quality standards specific to controlled substance manufacturing.
• Manage all quality-related documentation for the block, including reviewing and approving batch records, process validation protocols, and product specifications.
• Oversee and manage investigations into batch failures, deviations, and market complaints to identify root causes and implement corrective and preventive actions (CAPA).
• Handle all aspects of the Quality Management System (QMS) related to the manufacturing block.
• Ensure timely and compliant closure of all investigations and regulatory findings.

Regulatory and security management:

• Maintain strict adherence to all regulations governing controlled substances, including DEA and state-level controls.
• Support and coordinate with regulatory affairs and security teams for both internal and external audits, including inspections from regulatory bodies.
• Implement and enforce robust security protocols to prevent the diversion, theft, or misuse of controlled substances during manufacturing, storage, and transport.

Leadership and training:

• Lead, mentor, and manage the production team within the block, including performance management and grievance handling.
• Develop and implement training programs for all block personnel on SOPs, EHS (Environment, Health, and Safety), and regulatory compliance.
• Foster a culture of quality, safety, and continuous improvement within the manufacturing block.

Maintenance and EHS:

• Oversee the proper maintenance and upkeep of all manufacturing equipment and facilities.
• Ensure all EHS policies and practices are strictly followed to maintain a safe working environment.
• Monitor and control the generation of effluents and hazardous waste from the manufacturing process.