PURPOSE AND SCOPE:
Establishes, implements, maintains, and directs all objectives, requirements, standards, practices, and procedures of the assigned manufacturing site as the Plant Leader. Helps establish and manage production systems, quality standards, safety standards, personnel systems, financial systems, and other facility administrative systems. Responsible for the overall management and direction of the manufacturing, engineering, and facilities at assigned site.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Responsible for the overall management and direction of manufacturing operations at assigned site. Solid reporting line responsibility for Operations, Engineering, Procurement, and Supply Chain. Dotted reported line responsibility for Human Resources, Finance, and Information Technology.
Defines goals, objectives, and long-term strategies for a site with high complexity that is critical to the achievement of global business metrics and requirements.
Directs and controls the broad activities of the site through the interpretation, application, and implementation of company-wide policies and processes appropriate to the functional area.
Ensures that budgets and schedules are within company requirements with significant organizational responsibility for the overall control of planning, staffing, budgeting, expense priority management, and recommendation and implementation changes of current methods.
Directs and oversees production orders and schedules to ensure product quantities, product specifications, and scheduled delivery dates are available in order to plan operations of functional groups. Provides oversight in coordinating all operations pre and postproduction, including but not limited to: material procurement, material inspections, warehousing, and shipment. Ensures a coordinated effort between managers and supervisors of all functional areas.
Maintains open communications with sales and marketing teams to gain visibility of marketing strategies and sales forecasts.
Works with financial team to implement measures and metrics to ensure financial goals are met, including meeting cost standards, monitoring and maintaining operation efficiencies, development and implementation of cost reductions, and the development and meeting of operational budgets.
Oversees preparation of operation schedules and coordinates manufacturing activities to ensure production and quality of products meets specifications, customer demand, and customer expectations. Provides direction for all functional groups accountable to operations. Establishes priorities and sequences for manufacturing and shipment of products.
Reviews production and operating reports and performance indicators, and resolves operational, manufacturing, and maintenance issues to ensure minimum costs, prevent operational delays, and ensure product quality.
Collaborates with Quality Systems to ensure implementation and maintenance of quality standards, including meeting compliance/regulatory requirements, establishing, and achieving quality goals and objectives for the operation. Engaged in monitoring and managing regulatory compliance.
Ensures compliance with all applicable Federal and State government regulations.
Determines budgets, approves, and controls all costs of Manufacturing and Facilities. On a monthly basis, reports to senior management on causes for variances and appropriate corrective actions. Recommends and initiates improved methods and procedures resulting in lower operating costs.
Promotes and maintains effective relationships with management, governmental agencies, and customers in support of all matters within the scope of responsibility of the role.
Analyzes, evaluates, and presents information to senior manufacturing leadership concerning factors such as quality standards, production capabilities, manufacturing problems, people development, economic trends, and the production of new products within assigned facility.
Recommends alternative methods and procedures for resolving manufacturing problems/issues that may arise.
Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements, and operational procedures.
Conducts regular meetings with plant management team to establish clear expectations and to provide and receive feedback.
Reviews technical problems and procedures of assigned departments and recommends solutions to operational problems.
Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry.
Remains knowledgeable and current on SOPs, cGMP, ISO Standards (EN ISO 13485), Canadian Regulations, and other regulatory policies and guidelines.
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
Ensures all employees within the assigned teams understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations. Establishes and maintains effective internal systems and controls to promote compliance with these requirements.
Provides leadership, guidance and coaching for all direct reports to maintain an engaged and productive workforce. Partnering with Human Resources on employee matters.
Maintains general housekeeping of working area and plant.
Maintains a good attendance record.
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to use hands to finger, handle, or feel, and reach with hands and arms. The employee is occasionally required to stand, walk, sit, climb, balance, stoop, kneel, crouch, or crawl.
Must occasionally lift and/or move up to 50 pounds. Safety glasses and other PPE to be worn in specific areas.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and high, precarious places. The noise level in the work environment is usually moderate.
EXPERIENCE AND REQUIRED SKILLS:
Minimum 10+ years of related manufacturing operations experience.
5+ years of experience as a manager or in a senior managerial role.
Related experience in operations for personnel management, quality, budgets and finance, engineering and maintenance, and materials and resource planning.
Experience with the regulatory requirements of the FDA and Health Canada GMPs, OSHA, EPA, and IS.
Strong management skills with the ability to lead cohesive and productive teams.
Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
Excellent oral and written communication skills.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
Ability to respond to common inquiries/complaints from customers, regulatory agencies, and members of the business community.
Ability to write speeches and articles for publication that conform to prescribed style and format.
Ability to effectively present information to top management, public groups, and/or boards of directors.
Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Working knowledge of Business Management systems (i.e. SAP); Database software (i.e. MS Access); Human Resource and Payroll systems (i.e., PeopleSoft); Manufacturing software; Order processing systems; Project Management software; Spreadsheet software (i.e., MS Excel), Word Processing software (i.e., MS Word); and Presentation software (i.e., MS PowerPoint).
Reference ComplianceWire Curriculum.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care