Shire Jobs

This is a Job Description for a Quality Manager II -- Validations and Risk in Cleveland, Mississippi

Summary:

 This position is a key role in the Quality organization. Primary areas of responsibility will be leading activities related with Quality Engineering to provide technical support, and coordinate activities and projects of all documentation and quality operations for areas of responsibility, while assuring compliance with established standards. This key role is responsible for the overall direction, coordination, and evaluation of the unit. This role is responsible for carrying out supervisory duties in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and resolving problems. Additional focus will be on implementing continuous improvement, handling equipment/system upgrades, and new equipment/systems. Cross-functional teamwork and project management will be involved in this role as well. Responsibilities include hardware and software validation, integration of Six Sigma methodology/predictability into plant processes, paperless system implementation, process monitoring (SPC), data integrity requirements, and risk management oversight. The primary end results of this position are to assure all activities carried out through the site are properly performed in accordance with FDA guidelines and meet the overall business priorities and schedules.

Duties & Responsibilities:

Integrates the Six Sigma Process to Validations, Manufacturing and testing processes. Assures compliance to all software and hardware validation requirements as well as equipment and software life cycle. Assures compliance to data integrity initiatives and requirements. Support timely validation efforts throughout quality operational areas. Audits, creates, and implements changes to specifications and SOPs. Plays an active role on quality management teams within the organization. Supports implementation of VIP projects. Supports implementation of paperless systems. Supervise and support all area associates, assuring a teamwork environment. Trains and integrates new engineers / associates. Oversees training and cross training of direct reports. Evaluates changes to systems and ensures proper process is followed for implementation. Identify and implement improvements in laboratory testing methods and automation to upgrade laboratory efficiency, consistent with the lowest possible cost objectives of the business. Leads team in qualification of identified upgrades. Serves as a team leader to establish working teams. Maintain good working knowledge of plant systems, processes, procedures, documentation, and products. Manage and prioritize multiple tasks and projects. Serve as plant quality software and validation facility contact with corporate or outside interests. Develop and benchmark new technologies and methodologies for use in the facility. Promote innovation in quality operational areas. Manage financial goals for departments. Promote company security, industrial hygiene, cGMPs, and other policies established by the company. Perform tasks independently with minimum supervision. Travel as needed to perform duties. Ability to sit, stand and/or walk for long periods of time. Ability to reach above the shoulder. Ability to bend/stoop. Occasionally carry out duties of Quality Director or Operations Manager as needed. Must meet visual acuity requirements as documented in Baxter Cleveland Human Resources Procedure 1.04. Must have knowledge of both plant and department environmental health and safety regulations and follow said regulations accordingly. Must perform other duties and responsibilities as determined by supervision/management.

Requirements

and Qualifications[]{#Hlk142289191}[]{#Hlk142304825}

: Bachelor's degree in microbiology, Biology Chemistry or Engineering Required. 7+ years' experience in Quality, Manufacturing, Engineering or related field. 5+ years of leadership experience. Thorough knowledge of applicable procedures, specifications, regulations and standards. Strong analytical and problem-solving skills. Ability to lead/supervise a team of employees. Good communication and leadership skills. Good interpersonal/communication/influencing/negotiation skills. Good project management skills. Six Sigma Black Belt Certification or industry standard equivalent is preferred.

Equal

Opportunity/Affirmative Action Employer.