Director, Manufacturing Operations

Fresenius Kabi US•Wilson, NC

53d

About The Position

Responsible for the overall management, direction and coordination of manufacturing personnel and processes. Areas of responsibility include but may not be limited to: formulation, component preparation, filling, visual inspection and packaging. This position coordinates the execution of manufacturing schedules against sales forecast and plant capacity. Collaboration with department managers and/or supervisors along with support groups is necessary. Responsible for manufacturing budget, compliance against applicable cGMP's, regulatory requirements and company SOP's and policies.

Requirements

Bachelors of Science degree in related field or equivalent education and experience.
10 years of experience in pharmaceutical manufacturing in a cGMP environment required with 5 years of progressive levels of managerial experience and broad span of organizational control.
Excellent analytical and technical skills.
Excellent written and verbal communication skills. Must be able to communicate and interact with all levels of the organization and manage in a dynamic environment to meet plant and company objectives.

Responsibilities

Establishes and controls the processes and procedures for compounding, component preparation, filling, visual inspection and packaging.
Assist company officers and senior staff members in the development and formulation of long and short-range planning, policies, programs, and objectives.
Develop the manufacturing plan and establish procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards.
Achieve optimum employee levels with the least amount of overhead and raw material costs to meet annual budget.
Formulate and recommend manufacturing policies and programs that guide the organization in maintaining and improving its competitive position and the profitability of the operation.
Direct and monitor department managers and supervisors to accomplish goals of the manufacturing plan, consistent with established manufacturing and safety procedures. Act as a liaison between department management/subordinate levels, as well as executive/Supervisor levels to inform personnel of communications, decisions, policies, and all matters that affect their performance and results.
Hire, train, develop, and evaluate staff. Take corrective action as necessary on a timely basis and in accordance with company policy. Ensure compliance with current federal and local regulations. Consult with Human Resources Department as appropriate.
Identify, recommend, and implement changes to improve productivity, reduce defects and reduce cost and scrap, monitor scrap and rework data. Direct the establishment, implementation and maintenance of production standards.
Direct and coordinate efforts to improve Right-First-Time execution, reduce deviations and manage the prioritization of the deviation writers to close deviations needed for on time batch release.
Direct and coordinate various programs essential to manufacturing procedures (e.g., training, safety, housekeeping, cost reduction, worker involvement, security, etc.)
Initiate and coordinate major projects (e.g., plant layout changes, installation of capital equipment, major repairs, etc.)
Work effectively and relate well with others. Exhibiting a professional manner in dealing with others while working to maintain constructive working relationships
Keep current on information and technology affecting functional areas to increase innovation and ensure compliance
Participate in the preparation and presentation of site related business metrics and performance metrics, such as Line OEE achievement and production output, to upper-level management.
Support regulatory inspections and company audits as the Subject Matter Expert for the assigned departments under your control and engage direct reports as needed for support.
Perform miscellaneous duties and projects as assigned and required.