Quality Operations Director Job - (west chester, pennsylvania) in Philadelphia, Pennsylvania For Sale

Quality Operations Director:xxxxxxxx24
Description
Animas Corporation, a member of the Johnson and Johnson Family of Companies, is currently recruiting for a Quality Operations Director. This position will be based in West Chester, PA.
Johnson and Johnson is committed to improving outcomes for people living with diabetes by offering innovative and relevant glucose management products and services to best serve the needs of patients and their healthcare professionals. Today, the Johnson and Johnson family of diabetes companies includes blood glucose monitoring (LifeScan), insulin delivery (Animas), education and community for children and their families living with diabetes (Children with Diabetes), and healthcare professional product training and educational programs to improve care and outcomes (The Johnson and Johnson Diabetes Institute).
To find out more about (LifeScan OR Animas) visit (OneTouch OR animas).
Directs the Animas : West Chester Quality Operations organization, ensuring compliance with quality requirements , continuous supply to customers, compliance and regulatory agencies requirements, among others. Responsible for taking a leadership role in defining short and long term strategies for the West Chester facility.
Has direct accountability through direct reports, over inspection and release of incoming raw materials, in:process and final Quality inspection and testing. Directs the Quality Engineering team and Quality Systems site execution. Engages and collaborates with Franchise Quality teams as well as cross functional Supply Chain functions including Operations, Make Engineering, Production Planning and Logistics and Product management to assure a horizontal approach to resources management and prioritization.
Responsibilities:
Serves as local Quality Systems Management Representative for the West Chester site. Operates tactically within the operations environment to ensure practical and timely provision of Quality decision making. Oversee the management of the day:to:day quality activities related to the Animas West Chester site. Make decisions on non:conforming material and approves in:process and final Use:As:Is NCR's. Evaluates CAPAs for elevation to Risk Management Board and/or Quality Board. Assist in complex investigations and approve final technical investigation reports. Oversee site validation activities and approvals. Develop the site operational Quality strategy as a business partner to Supply Chain Operations and Franchise QA functions to optimize the performance of operations, compliance, and quality systems as well as influence the global integration and alignment of goals across the organization. Host for 3rd party audits; participate and present in Quality and Compliance Executive Reviews, Management Reviews, Quality Boards and others as requested/required. Evaluate West Chester's Quality Operations' capabilities, identify gaps, and recommend issue resolution to Executive Management. Develops and leads innovative initiatives to improve business performance to support visionary changes. Provide coaching and staff development, manage performance, succession planning, and departmental budget. Accountable for organizational capabilities to meet current and future business needs. Serve as a technical expert for functional area, with conceptual knowledge of all quality functions and business areas. Serve as Subject Matter Expert (SME) for execution of Quality Systems in West Chester during inspection readiness activities. Support the preparation of any communications with FDA related to any follow:ups to inspections carried out in West Chester. Directly supports the deployment of Quality Systems improvements, standards and policies. Observe all Company's Environmental, Safety, and Industrial Hygiene policies and regulations.
Qualifications
A Bachelor Degree in Science or Engineering is required. A minimum of 10 years of experience in the Medical Devices or
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