Sr QMSR Manager

PURPOSE AND SCOPE:

Develops, implements, and maintains the activities of quality systems. Oversees development and implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products. Makes recommendations for corrective action necessary to ensure conformity with quality specifications. Ensures finished products conform to government and company standards and satisfy good manufacturing practices regulations.

• Manages the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing.
• Provides leadership, coaching, and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters.
• Interprets company-wide policies and procedures. Involved in the development, modification, and execution of company policies that affect immediate operations with potential company-wide effect. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
• Establishes standard and meaningful objectives and metrics that align to goals, mission, and objectives for applicable department/program. Develops and distributes metrics to support the business.
• Analyzes and reports on trends, and other areas of quality data on a periodic basis.
• Reports on key performance indicators associated with program effectiveness.
• Generally manages department budget and day-to-day functions. Develops budgets, schedules and performance standards. Exercises supervision in terms of costs, methods, and staffing.
• Ensures goals and objectives are aligned between Corporate and sites, including those of the Corporate QMS.
• Interacts frequently with internal departments and external customers/vendors; particularly in problem resolution. Responsible for hiring, coaching, and counseling employees, including performance reviews, disciplinary action and terminations.
• Remains current with industry standards and best practices to promote activities necessary for the evolution of the quality management system.
• Ensures procedures are clearly defined and implemented to fulfill regulatory and business requirements. Identifies areas for continuous improvement of these procedures (best in class).
• Ensures documents are properly maintained, with good documentation practices, for all manufactured and distributed products, quality system processes, and applicable services.
• Keeps up-to-date on new regulations and standards that affect the program.
• Ensures the development and maintenance, as appropriate, of data collection and analysis systems including the development, rationale, and review of process and product specifications.
• Ensures the establishment of accurate and robust company, site, department, and role-based training requirements/assignments.
• May assist corporate and various sites with the preparation of regulatory responses and periodic updates.
• Provides technical guidance.
• Assists with various projects as assigned.
• Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee may be exposed to moving…