Sr. Manager, Production (PFS)

Fresenius Kabi•Wilson, NC

About The Position

Responsible for the overall management, direction and coordination of production personnel and processes for a 7 day/24-hour operation; including compounding, component preparation, aseptic and terminally sterilized filling, and packaging operations for the syringe plant. This position coordinates the execution of production schedules against sales forecast and plant capacity. Direction to department supervisors along with interaction among support groups is necessary. Manager is responsible for compliance against applicable cGMP’s, regulatory requirements and company SOP’s and policies. Delegation and direction to subordinates while coordinating defined responsibilities is a critical part of this role.

Responsibilities

Coordinates execution of production schedules based upon direction from site master planner.
Interacts with departmental managers and supervisors on compliant application of methods, standards, safety programs, and cGMP’s.
Directs and coordinates the activities and performance of assigned staff to achieve department objectives and performance goals.
Establishes and recommends clearly defined production objectives while developing specific short-term and long-term strategic initiatives.
Plans, defends, and presents related budgetary activities to include availability of adequate resources to manufacture and package product (equipment, supplies and labor).
Regularly evaluates operational results making necessary modifications as required.
Identifies, performs and leads continuous improvement projects to improve Safety, Quality, Cost and Capacity.
Applies quantitative and statistical analysis to decision making.
Advises department management on matters relating to daily operations and makes recommendations for improvements when feasible.
Reviews, performs/ensures investigations are done effectively and in a timely manner.
Develops and executes organizational planning to ensure adequate staff development.
Establishes effective communication methods to provide continuity of information across all shifts.
Maintains compliance with company policies, cGMP’s, safety standards, and good housekeeping practices.
Interacts with all regulatory agencies and customer audits as necessary.
Reports on the department’s performance through performance metrics/activities.
Assumes other duties as assigned.
Collaborates with the Environmental Management System Representative for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.
Collaborates with the Energy Management System Representative for ensuring that Energy Management Requirements are met under ISO 50001 standards.
Collaborates with the Occupational Health and Safety Management Representative for ensuring compliance to Occupational Health and Safety is met under ISO 45001.