Job Summary:
The Production Manager is responsible for managing all aspects of production operations, ensuring that production processes are compliant with company policies, safety requirements, quality requirements, and regulatory requirements. This role involves leading production teams, managing production plans, and promoting production efficiency and continuous improvement. The Production Manager will oversee the Production team and provide strategic direction and leadership to the entire production department.
Essential Duties and Responsibilities:
Include the following. Other duties may be assigned.
- Oversee the entire production operation to ensure compliance with company policies and regulatory requirements.
- Develop and implement production strategies to achieve company objectives and production targets.
- Review production orders and plans to ensure qualified products are produced within schedule.
- Lead teams to analyze production variances and take effective corrective actions.
- Push for equipment management and maintenance to support production plans.
- Promote lean manufacturing and continuous improvement initiatives using VSM, cell line, and other lean tools.
- Monitor quality checks and resolve production quality issues, ensuring compliance with ISO13485, ISO9001, and FDA regulations. Lead FDA inspection and external audits related to production ownership areas with 0 audit findings goal.
- Manage labor and maintain a safe and efficient work environment, leading 5S and EHS activities in the production department.
- Train and motivate production teams, ensuring timely completion of work and continuous skill development.
- Participate in management reviews and coordinate with other departments to achieve production goals.
- Drive department performance through production and quality metrics such as output yield (FPY, FY), production schedule OTD, daily fill rates, and cost control.
- Ensure effective resource allocation, including labor, materials, and equipment.
- Support process refinements, qualifications, and validations, including equipment and material specifications.
- Ensure complete and accurate documentation of production processes.
- Ensure all procedures under production ownership are effective and efficient, making sure actual practices follow documents with zero gaps.
- Conduct regular workplace inspections to identify and rectify unsafe conditions.
- Oversee health and safety within the production department, including accident investigation and corrective actions.
- Ensure environmental aspect and safety hazard risk assessments are conducted and controlled.
- Report all occupational accidents and incidents immediately and support EHS Committee Management Representative in investigations.
- Enforce compliance with EHS management systems and relevant legal and other applicable EHS requirements.
- Provide leadership and direction in EHS internal and external audits.
- Coordinate and communicate with other departments to support production goals.
