JOB DESCRIPTION: MAIN PURPOSE OF ROLE Leadership position that directs all activities within the Quality function for a single site business including: Implement and maintain a QMS to ensure compliance with Division and Abbott policies and procedures and applicable regulations. Deliver safe and effective products that meet customer needs while maintaining compliance with Division and Abbott policies and procedures and applicable regulatory agency requirements. Select, train and develop key staff to ensure availability of resources to support the Quality Management System (QMS) objectives along with short and long term business goals. Serve as the Quality System Management Representative for the site. Participate as a member of the on- site senior management team. Develop and maintain a culture where Health and Safety is an individual and collective responsibility. MAIN RESPONSIBILITIES · Ensure quality system and policy compliance to local and international regulations that are applicable to markets served. · Manage the Quality Assurance staff, their training and development to support all elements of the QMS. · Develop key quality metrics/indicators to track performance and compliance and analyse data to identify trends and implement continuous improvement. · Manage the CAPA process including non -conformances, audit findings and customer complaints. · Support/ manage(if applicable) any activities related to field actions. · Address Health and Safety concerns within applicable areas to reduce hazards and risk. · Support cost improvement programs and projects without compromising quality or compliance objectives. · Lead to assure that communications, interpersonal interactions and business behaviours are consistent with the Abbott Code of Conduct. · Manage site QA personnel to assure site and division QA goals, duties, and responsibilities are met and/or exceeded. · Develop/ manage resource and budget (expense and capital) requirements associated with Quality related activities. · Evaluate new regulations to assure on going compliance and determine impact to the business. · Drive the organization to a high level of customer service while maintaining compliance. · Work with applicable functional groups to ensure that new products are delivered per the agreement project timelines. · Maintain the Supplier/ TPM on-site program. Implement Division projects/ programs as required. · Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management. · Manages up to 15 direct reports and up to 100 Indirect reports. EDUCATION / EXPERIENCE · Minimum of a Bachelor’s or advanced degree in a technical discipline including however not limited to life, physical or food based science or engineering. · 5 years Quality Assurance/Quality Control experience in the medical device, diagnostic or nutritional manufacturing or pharmaceutical industries. · 5 years in a management/supervisory position. Concurrent experience is acceptable. Working knowledge of applicable regulations and standards (for example, FDA, QSR and ISO ). The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ADC Diabetes Care LOCATION: United Kingdom > Witney : Production Facility ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable