Quality Systems Manager
Provision People - Indianapolis, IN
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Relocation assistance is provided to the qualified candidate!Summary: Our award-winning client is seeking a Quality Systems Manager to join their team. The Quality Systems Manager (QS Manager) plays a pivotal role in embedding quality into the core of our operations and throughout the entire life cycle of our products. This role involves overseeing the creation, implementation, and maintenance of procedures, processes, and programs that drive both Quality and Engineering systems, ensuring compliance with hygienic standards and industry best practices. An essential aspect of the position is identifying and implementing measures of system effectiveness while maintaining vigilant monitoring. Responsibilities: Develop, deploy, and maintain the Organization's Quality Policy Manual and associated Standard Operating Procedures (SOPs). Lead and manage the Quality Management System (QMS) process from Research and Development (R&D) through operations. Serve as the primary point of contact for Customer Facing Healthcare Quality Management (HCQM), ensuring customer needs are met. Act as the key contact for customer audits, document requests, and routine communications. Manage the application of the Quality Monitoring Scheme (QMS) to document quality requirements for each product from R&D through manufacturing. Ensure alignment with Manufacturing Specifications (MSPEC) and adherence to quality standards. Develop and report Key Performance Indicators (KPIs) for the QA Department. Manage shelf-life monitoring and extensions for both raw materials and finished products. Oversee document control, Pest Control, Management of Change, and continuous improvement initiatives. Required Qualifications: Bachelor's degree in Food Science, Food Engineering, Chemistry, or a related field. 10+ years of experience in a cGMP environment. Experience in manufacturing aseptic products and thermal processing. Knowledge of system design and experience in implementing robust sustainable programs. Familiarity with Lean Six Sigma tools; Belt or Black Belt certification preferred. Effective communication skills, both verbal and written, with the ability to engage stakeholders at all levels. Commitment to ensuring Quality by Design from ideation through commercialization. Engineering Systems: Develop and implement Engineering systems to manage buildings and equipment throughout their life cycle, including the adoption of new technologies, testing and validation of equipment, and addressing obsolescence. Participate in and provide input to the design of products and processes. Drive Quality in Execution: Enhance accessibility and utilization of the Quality Monitoring Scheme (QMS). Act as the customer-facing HCQM contact, translating customer requirements into the quality system. Prepare for and represent the organization as the primary contact for all customer audits. Continuous Improvement: Identify process waste and lead initiatives to drive improvement. Utilize Lean Six Sigma tools to enhance systems and processes. Additional Responsibilities: Perform any other duties as assigned.
Created: 2026-03-10