Primary Function / Primary Goals / Objectives
The Director Global Technology QA serves as a global leader for planning, standardizing and implementing validation, calibration, Software Life Cycle (SLC) and Software QA (SQA) requirements worldwide. The Director serves as a business owner for division-level ANQA IT applications.
The area provides QA support for high impact, division-level projects to ensure user needs and validation/calibration/SLC/SQA requirements are met. Projects supported include implementation of new manufacturing technologies and processes, construction of greenfield sites, development and deployment of corporate and division-level IT systems.
The Director represents AN on corporate and division level validation/calibration/SLC/SQA initiatives and process improvement teams. The Director acts as a liaison between corporate and AN facilities in the areas of validation/calibration/SLC/SQA.
The Director/staff are responsible for development and implementation of division validation/calibration/SLC/SQA policies and for providing subject matter expertise (SME) to the global AN organization. The manager/staff develop and execute strategies to ensure global compliance and consistent application of these policies. The Director/staff train and provide guidance to AN personnel globally for the policies owned.
- Implement and maintain the effectiveness of the Abbott quality system with concentrated focus in the areas of validation, calibration, SLC and SQA.
- Function as owner and Quality SME for division-level validation, calibration, SLC and SQA policies. Interface/benchmark with sister divisions and other companies to establish and maintain effective and best-in-class division policy and quality systems. Drive for process simplification and efficiency. Provide direction, consultation and validation/calibration/SLC/SQA training to AN facilities worldwide.
- Develop and champion strategies, manage resources to drive quality improvement opportunities associated with validation/calibration/SLC/SQA activities. Drive changes to completion.
- Build effective working relationships with value chain, e.g., Engineering, AN IT, GIS, AQR, to ensure LRP strategy and business goals are achieved.
- Determine the staffing and structure needed to support designated projects, achieve regulatory compliance and business objectives.
- Provide leadership and represent QA interests for high impact, corporate and division-level projects, as requested. Delegate responsibilities to staff, as appropriate. Ensure implementation of requirements, e.g., global and local validation standards, 21CFR Part 11, privacy laws. Review and approve protocols and reports, as necessary.
- Represent AN on corporate validation/calibration/SLC/SQA committees. Deploy best practices globally.
- Develop recommendations and author QA IT strategy documents to meet AN QA LRP needs. Assist in the development of the division IT LRP.
- Provide input and support development of manufacturing site Validation and Calibration Plans.
- Represent division-level validation/calibration/SLC/SQA requirements and activities during external and internal agency audits, as necessary.
- Manage Division SQA, Technology QA, Validation and Calibration QA personnel and determine department priorities. Assure staffing continuity through talent management and succession planning. Provide administrative responsibilities including performance reviews, organizational inventory and talent development.
Bachelors degree required, in a technical or scientific discipline (preferred). Education or experience in Engineering or Computer Science is highly desirable. Equivalent experience (e.g., 10 years in a Quality, Engineering or Operations role including 5 years supervisory/management experience) will be considered. Advanced degree a plus, but not required. Competency in program management with general knowledge of business Information Technology systems strongly recommended.
Effective communication skills, tact and diplomacy are required. The incumbent must be capable of interfacing successfully with multiple functional areas and levels of management. In addition, the incumbent must be capable of understanding and overcoming cultural differences and language obstacles to provide solutions that satisfy corporate, division, global and local objectives.
Professional certification from an accrediting body (e.g., ASQ) recommended, but not required.
Accountability / Scope / Budget
- The incumbent must have sound quality principles. Knowledge of corporate and division validation/calibration/SLC/SQA policies and/or industry standards is expected. Practical knowledge of Quality philosophies, e.g., Six Sigma, Lean, TQM, is recommended.
- The position requires effective leadership and management skills, including risk-based decision making, problem-solving, and the ability to manage change.
- Effective oral and written communication skills are essential. Presentation skills are a plus.
- The incumbent must have effective human relations and administrative skills to manage direct reports and to influence others that do not directly report.
- Proven project management skills with the ability to manage multiple projects in a cross-functional environment is required.
- Practical experience interfacing with global businesses is a plus.
The Director Global Technology QA reports to the Senior Director of AN Quality Systems. The position requires the ability to work autonomously and to make decisions independently.
The Director/staff provide QA leadership and support for high-impact, multi-million dollar, corporate and division-level projects that represent significant financial impact and quality/compliance risk for the division. Unsuccessful QA contribution can result in poor performance of the project deliverable (e.g., equipment failure, incapable processes, user needs not met), project delays, and/or compliance issues. These failure modes can have significant adverse financial impact for the business. Effective management of permanent and temporary project QA resources are included in the job scope
Validation and Information Technology can be highly scrutinized by regulatory entities (e.g., FDA) during audit. Failure to achieve compliance for these projects can result in significant regulatory and financial penalties.
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