Regulatory Operations Lead
5 days ago
About Hassett
Hassett is a pioneering company in regenerative medicine, dedicated to delivering transformative health innovations. As we continue to expand, we are seeking a strategic and experienced leader to oversee our manufacturing activities and ensure seamless production aligned with Good Manufacturing Practices (GMP).
About the Role
The Head of Operations is a crucial position that requires close collaboration with our Head of Quality to ensure strict adherence to industry standards. Key responsibilities include scheduling, equipment and materials management, supply chain coordination, and implementing operational improvements.
Key Responsibilities
- Develop, implement, and maintain procedures for manufacturing activities within a GMP environment, ensuring company and partner products meet regulatory standards.
- Forecast, establish, and maintain operational procedures, work schedules, and equipment layout, with an emphasis on digital platform integration.
- Ensure the facility meets validation requirements as defined by regulatory bodies.
- Set manufacturing KPIs, report on progress, and implement continual improvement initiatives to maximize efficiency and meet financial targets.
- Schedule and oversee calibration, maintenance, pest control, and cleaning activities to minimize production interruptions.
- Effectively manage support staff, ensuring resource availability aligns with project needs and forecasted demand.
- Oversee planning, warehousing, and supply chain operations to meet DIFOT, unit cost, and quality standards for both the company and partner products.
- Drive cost reduction initiatives to enhance market competitiveness.
- Implement risk management protocols that prioritize product quality, patient safety, and business continuity.
Requirements
- Experience in optimizing processes for efficiency and quality.
- Strong ability to lead and mentor cross-functional teams.
- Extensive experience in GMP environments with a proven track record in facility and process management.
Qualifications & Experience
- Postgraduate degree in Science, Engineering, or a similar discipline.
- Strong knowledge of GMP manufacturing with practical application experience.
- Extensive experience managing support staff and using plant/process equipment.
- Proficiency in supply chain, materials management, distribution, and cold chain shipping.
- Project management skills, ideally using MS Project, in a regulated environment.
- Proven ability to troubleshoot operational challenges and lead teams.
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