Manage through subordinates the coordination of the activities of multiple sections of the Quality organization. Is responsible for results in terms of product quality and conformance to regulations and Baxter quality policies.
Ensure suitability and effectiveness of the Irvine Quality System and compliance with applicable domestic and international regulations, directives, and standards.
Essential Duties and Responsibilities:
- Manage the activities of a section or department in the Quality organization with responsibility for results in terms of product quality, performance and safety.
- Implements the quality systems procedures and manages compliance in a section or department.
- Understands and assures conformance to regulations in a section or department. Interfaces with regulators during regulatory inspections.
- Develops budget for a section or department and ensures adherence to the budget.
- Manages the coaching, training and development of subordinates.
- Participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
- Interacts frequently with subordinate supervisors and functional peer group managers
- Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
- BS in science or engineering; 5+ years experience in Quality, Manufacturing, Engineering or related field which should include 1-2 years of supervisory experience
- Thorough knowledge of applicable procedures, specifications, regulations and standards.
- Experience with system re-engineering, process improvements, Lean Management & Six Sigma
- NCR/CAPA experience and the ability to lead complex investigations with appropriate root cause to prevent recurrence
- Change Control experience with product design, product requirements, intended use, product related processes, facilities, suppliers and QMS system changes.
- Experience with management of Training systems/programs ensuring compliance and providing efficient/standardized methods for execution of cGMP training requirements.
- Strong analytical and problem-solving skills, demonstrated use of DMAIC tools and concepts used within complex problem solving
- FDA knowledge/experience in Data Integrity (Regulation) and implementation of successful ALCOA standards. Strong command of Baxter Quality systems and processes (Enterprise Management System (EMS), Trackwise 8, Trackwise 9, Team Center Unified (TcU), Kronos, Coupa).
- Ability to manage/supervise a team of employees. Communicates company goals, safety practices, and deadlines to team. Motivates team members and assesses performance. Keeps management updated on team performance
- Proficiency in computer applications (Word, Excel, Outlook, PowerPoint, Visio, Project).
- Good interpersonal/communication/influencing/negotiation skills.