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Senior Director, Site Quality – Sterile Manufacturing

ICU Medical

This is a Full-time position in Austin, TX posted July 10, 2021.

FLSA Status: ExemptPosition Summary:Working under the general direction of the Corporate Vice President, Quality, Regulatory & Medical Affairs, leads a staff of professionals, technicians and administrative personnel.The primary responsibility of this position is to direct the activities of the Quality Department for the Austin facility which manufactures IV bags and the nearby Round Rock facility, which manufactures the film. Ensures the operation is managed in accordance with established Corporate Quality standards and all regulatory compliance in order to ensure that proper controls are instituted and maintained on incoming and in-process materials and finished product. The incumbent has final authority and responsibility for the release or other disposition of finished products produced in the Austin plant. The Austin Quality Department also oversees the manufacturing and release of IV Solutions products from contract manufacturing sites and is the primary interface for products the ICU Medical Austin site contract manufactures for other customers.The Austin Quality Department provides the assurance that the product produced within the facility will be in conformance with the Corporate quality requirements. This will be accomplished through statistical sampling techniques, inspection and testing; utilizing specifications, procedures and technical information. Furthermore, the Department assures compliance with the requirements of Regulatory agencies such as the US Food and Drug Administration (FDA) and international regulatory agencies. The incumbent will act as the official agent in managing regulatory investigations and inspections.To accomplish these objectives, the Quality Department is divided into several sections such as Manufacturing Quality Assurance, Compliance, Chemical Quality, Incoming Quality, Biological Quality, and Risk Management. Each section is staffed with Directors, Managers, Supervisors, Technicians, and Administrative personnel of varying academic and experiential background.The Austin facility has manufacturing release and distribution responsibility for a major percentage of ICU Medical products. The Quality function, therefore, must be technically oriented in chemical and microbiological disciplines, as well as in all quality systems.Essential Duties & Responsibilities:* Establish the Quality strategy for the facility.* Develop, recommend and implement objectives, goals, policies, budgets and plans for programs and organizational arrangements aimed at the most effective utilization to the Quality organization. Review performance against these goals, plans and budgets, taking corrective action where indicated.* Assure the Quality organization is technically trained and qualified to:Receive, sample, inspect and test by chemical, physical, biological and mechanical means raw materials and supplies and render a decision for appropriate disposition based upon data generated, specifications and technical judgment.Monitor, sample, inspect and test by various means the manufacture of products, developing data to support release when in conformance with specifications and standards.Provide technical support to the total plant operation, trouble-shooting plant quality problems when they arise.Monitor the environment of the plant, its support systems and production processes and equipment to assure the implementation of and conformance to regulatory requirements, and to assure the manufacture of products meet biological standards.* Provide a constant review of the manufacturing process and related equipment to assure compliance with procedures, specifications and policies.* Provide the technical expertise to further assure the timely, efficient and compliant introduction of new products into the Austin plant.* Keep the department and plant organizations abreast of the policies and regulatory changes of the FDA and similar federal regulatory organizations as well as state and local departments of health or regulatory bodies. The incumbent represents the Corporation during any visit or inspection by a regulatory authority.* As necessary, develop, implement and maintain informational systems to further assure effective utilization of data, trends and specifications and procedures. Assure the maintenance of adequate records and samples of raw materials, manufactured chemicals, finishing supplies and final products.* The incumbent will work with key subordinates and with the plant staff and other departments to implement approved policies, goals and profit plans. This includes but is not limited to:Assisting Materials Management to assure the availability of sufficient inventories of raw materials and supplies as may be required by the plant. Further, to develop strong partnerships for existing sources of supply and investigating, evaluating and approving new sources of supplies where necessary.Assisting Manufacturing to assure the manufacture of products of the desired quality levels and in accordance with procedures and stated schedules.Assuming the responsibility for the approval, rejection or restriction of each lot of raw material, finishing supplies and final product.Assisting Engineering in development of appropriate manufacturing processes and related equipment and controls for existing and new products.Working with Engineering and Accounting in development of operating and capital plans for the Quality department prior to submission to the Vice President, US Pharma Quality OperationsWork with and obtain the counsel of the Human Resources Department in employee hiring, development, compensation, performance and appraisal, promotion, demotion or dismissal.* Maintain cooperative relations with all departments within Corporate Quality.* Perform other related duties as assigned or required.Knowledge, Skills & Qualifications:* Must have demonstrated the ability to effectively interface with Federal regulatory agents during the normal execution of their duties.* Communication skills, tact, and diplomacy are critical to the performance of position requirements.* Knowledge of the philosophy, theory, practice and broad principles of Quality as applied to the pharmaceutical and medical products field is required.* The incumbent must possess a high level of human relations skill to direct and develop a large technical, professional staff.* The incumbent must possess well-developed managerial skills.Education and Experience:* Bachelor’s Degree is required: Technical (Chemistry, Biology, Microbiology, or Engineering)* A minimum of 10 years of direct experience in a pharmaceutical (bag manufacturing preferred), or similar industry is required, with no less than five years of experience overseeing plant quality.* Preferred experience with high volume sterile injectables or similar products with steam based terminal sterilization at a Director level.* Experience or prior roles in manufacturing function preferred.* The incumbent must have at least ten years of experience in the interpretation and application of FDA regulations and GMP requirements along with experience in interfacing with FDA during inspections and other compliance matters.* Must have demonstrated experience building high performance teams along with maintaining and improving compliance, ability to influence the organization and help set the strategy for the facility/business.Minimum Qualifications:* Must be at least 18 years of age.Travel Requirements:* Typically requires travel less than 5% of the time.Physical Requirements and Work Environment:* Office, manufacturing and clean room environments.* Must be able to wear appropriate gowning required for entry into areas.ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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