As the Operations Leader, you will lead the production of high-quality pharmaceutical drug products in a dynamic and regulated environment. You will ensure your team consistently delivers on operational objectives, compliance standards, safety, and continuous improvement initiatives. This is a highly visible and rewarding leadership role for individuals committed to quality and operational excellence.
Key Responsibilities:
- Oversee and execute all drug product manufacturing operations, ensuring compliance with internal and external regulatory standards (including cGMP, HPRA/FDA).
- Provide leadership, direction, and motivation to a team of 8-45, ensuring effective performance, strong communication, and development of team members.
- Plan staffing and material resources to guarantee smooth, efficient, and safe daily operations.
- Coordinate onboarding, training, and ongoing skills development for team members.
- Monitor and manage key performance indicators for the department (e.g., yield, production rate, resource usage, attendance, overtime).
- Maintain accurate records and timely updates in manufacturing and personnel systems.
- Foster a culture of safety, quality, innovation, and continuous improvement throughout the manufacturing area.
- Collaborate with other shift leaders and cross-functional teams to deliver operational results and support site-wide projects.
- Lead and support facility and equipment/process improvements and Operational Excellence (OpEx) initiatives.
- Ensure compliance with safety, environmental, and quality SOPs, and manage adherence to all relevant procedures, policies, and regulations.
- Support HR processes including performance management, annual reviews, and employee relations.
- Lead the department in preparation for internal and external regulatory inspections/audits.
- Demonstrate flexibility regarding shift work and working hour requirements to meet business demands.