Plans, directs and manages the work of assigned Quality; provides technical leadership to corrective and preventive action (CAPA), deviation and change controls as necessary to ensure each project within the group is completed in accordance with departmental mission. Establishes department mission statements.
Support validated systems of rfxcel by ensuring all validation activities are completed, maintained and regularly reviewed to ensure compliance to intended use
Participation in External Audit, Support Director with site customer audits
Provides oversight for the development of projects related to quality systems and continuous improvements programs.
Proposes and executes process and procedural changes to improve process performance, robustness, productivity and efficiency. Applies metrics to departmental mission to drive continuous improvement.
Collaborates functionally and cross-functionally to implement Quality strategy and objectives. Performs both independently and in team settings. Works closely with department Director to set and implement goals.
Drive risk management activities, with the support of the director, within the SDLC and Change Control processes
Serves as Leader for new initiatives relating to department. Removes barriers to successful implementation and works to resolve them.
Ensures that all team members are compliant to all training materials and ensures timely completion of all trainings.
Provide on-site training to teams to ensure comprehension of procedural updates and documentation of training records
Skills/Experience
Requires a minimum of a Bachelor s degree in a science related discipline; Advanced degree
Requires a minimum of eight (8) years experience within a Quality unit with demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the
Minimum Four (4) years project management experience in a regulate industry