Manages a multiple modality or multiple irradiator processing facility or multiple facilities as a profit center(s). Responsible for all phases of plant operation, including supporting sales, production, distribution, Customer service. Duties include adherence to regulatory agency, ISO9001 and ISO13485, and Quality System policies and procedures. Ensures positive employee relations and a safe working environment, as well as monitoring financial performance of processing facility.
- Establishes an organizational structure by assigning responsibilities, delegating authority and selecting, orienting and training direct reports.
- Leads facility organizational staff by coaching, counseling, motivating and disciplining as needed; plans, monitors and appraises job results; directs and maintains activities designed to achieve and maintain high employee morale; fosters intra- and inter-department cooperation.
- Achieves financial objectives by preparing operating budget, scheduling expenditures, analyzing variances, compiling and studying costs and initiating corrective actions; requesting assistance from internal financialsupport as needed.
- Ensures a safe, clean and secure working environment by establishing and enforcing procedures, rules and regulations; by initiating fixed capital requests; monitors all production related safety and security systems and procedures on a regular basis; chairs plant safety meetings that evaluate plant machinery, equipment and working conditions; assuming the role as Radiation Safety Officer (RSO) as defined in the facility?s radioactive materials License (if applicable).
- Meets processing requirements by managing production staff in the most effective manner; monitors predetermined preventative maintenance measures designed to minimize equipment related downtime; ensures development of adequate plan for cobalt and/or ethylene oxide requirements in the most economical manner.
- Ensures compliance with Corporate QSRC and GMP procedures by initiating and monitoring related training programs.
- Ensures compliance with all pertinent corporate, federal, state and local regulations and licensing requirements by keeping abreast of current and developing requirements; instituting and monitoring internal compliance programs and procedures; ensures that plant tours for visiting external regulators are properly conducted.
- Minimizes and resolves internal complaints and grievances with the assistance of the Director of Plant Operations and liaison with Human Resources and Corporate Counsel, if appropriate.
- Maintains professional skills, knowledge and abilities by attending educational workshops, reviewing professional publications and participating in professional societies.
- Provides protection to employees by promoting personal protection and issuing monitoring devices in hazard areas as required by safety rules.
- Directs and administers current and new business activities by developing plans and strategies to meet Customer requirements and maximize profit; provides current or prospective Customers tours of the facility; leads internal, regulatory or Customer audits.
- Meets Customer requirements by managing plant operations according to established company policy; directs and coordinates all activities within the plant; coordinates requirements with Director of Plant Operations, sales, engineering, procurement, production, shipping/receiving, maintenance, quality functions and technology centers.
- Monitors implementation of plans and strategies by collecting, analyzing and preparing reports for review by appropriate company management.
- Minimizes and resolves external business related complaints by maintaining liaison with local and Divisional QSRC staff, and facility staff to investigate and resolve Customer issues.
- Promotes and protects the company reputation by participating in and representing the company in local community activities.
- Strives for continuous improvement by analyzing new or alternative ways to improve operations; incorporates staff suggestions into analysis by responding to audit activities in a constructive manner and use findings to improve operations where possible.
- Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the GMP and other directives; supporting the directives and decisions of higher level management and accomplishing other duties as assigned.
- Through review of all reporting and transactional procedures, ensures the integrity of financialreporting and transactional procedures in support of Sarbanes-Oxley, section 404 compliance.
- Communicates in an effective manner by utilizing accepted business practices in a courteous and professional manner to provide timely and accurate responses and service oriented offers of assistance.
- Protects company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
- Exhibits a commitment to the AST (Applied Sterilization Technologies) shared values of Customer Satisfaction and Continuous Improvement through ensuring defect-free workmanship, assisting others to meet the Customer?s needs, searching for efficient and effective ways to reduce waste, being active and accountable for Customer satisfaction, and satisfying the Customer?s needs with a sense of urgency.
- Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the GMP, Lean principles and other directives; supports the directives and decisions of higher level management and performs other duties as assigned.
Required Experience and Education
- A minimum of ten (10) years of managerial experience in an ISO and/or GMP related industry with strong Customer focus.
- Ability to effectively read, write and verbally communicate in English.
- Ability to work independently under general guidelines and supervision.
- Requires computer literacy to include word processing, spreadsheet and relevant software applications capabilities.
- Above average organizing, analyzing and a minimum of Level 3 math skills (ratios, proportions, basic algebra) to determine organizational Customer and regulatory problems to formulate corrective action plans.
- Effective interpersonal skills as demonstrated through prior management experience.
- Ability to adapt to changing duties and responsibilities.
- Ability to influence people in their opinions, attitude or judgements; to generalize, evaluate and make decisions in stressful situations.
- Normal hearing range sufficient to hear alarms, bells, horns, etc.