Regulatory Quality Management Systems Lead
The Regulatory Organization has an opening for a Quality Management Systems Lead. The successful candidate will lead the Regulatory effort focused on the development, coordination and implementation of an overall quality strategy for the Regulatory organization. The candidate will have experience in developing and establishing an integrated strategic quality vision. The role will include defining a long range strategic plan and the quality policies required to support the execution of the vision. The QMS lead will work with senior leadership to ensure appropriate standards are developed along with systems to ensure adherence to standards and processes along with system optimization and continuous improvement.
Specific Program Deliverables:
Develop a strategic quality vision for the Regulatory organization balancing risk management, regulatory compliance and cost effectiveness.
Assess current as-is state within Regulatory and define future state relative to quality systems.
Define and lead a cross-functional Regulatory Quality Leadership Team (QLT) that defines a foundational quality system optimized to meet the quality needs of teams consist with the overall quality standard.
In partnership with the QLT, design a strategy to modify foundational system to meet specific needs of groups across the Regulatory organization.
Lead cross functional working groups to define and execute implementation strategy. Teams will define quality work flows, systems and documentation to meet the overall quality standard. In addition, the working groups with evaluate and optimize QC/QA processes required to support the Quality Systems.
Coordinate decision making and actions relative to quality systems to ensure standards are met and processes are functioning effectively.
Assure systems deliver appropriate compliance as required by business needs.
Optimize existing IT reporting systems to identify quality system risk, identify trends and address continuous improvement.
Formal training in Quality Management Systems and proven success in developing multiple QMS approaches to meet quality standards.
Demonstrated experience in QMS system development and implementation both in a regulated and non-regulated quality environment.
Demonstrated ability to monitor quality system effectiveness, performance and address continuous improvement.
Experienced in risk analysis. Able to quantitate and articulate risk in order to develop global strategy and mitigation approaches.
Skilled in cost analysis and cost management. Able to use financial acumen and work with fiscal responsibility when developing systems.
Ability to understand and engage in a highly technical business framework. Ability to comprehend complex platforms as they relate to field, plant and laboratory operations and processes.
Visionary thinking to anticipate needs and set strategic direction.
Ability to build cooperative teams with diverse perspectives and needs.
Demonstrated experience in influence, agility and flexibility.
At minimum, required education and related work experience:
Degree in sciences: biological, agricultural, chemical or life sciences
10 years experience in the development and management of Quality Management Systems
ASQ Manager of Quality/Organizational Excellence Certification or equivalent
Lean / Six Sigma formal training and application.
Monsanto - 23 months ago
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