Plant Quality Manager - Manufacturing, Life Sciences; Clearwater, FL

Plant Quality Manager - Manufacturing, Life Sciences; Clearwater, FL

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Overview

The Plant Quality Manager for Saint-Gobain Life Sciences ensures the plant complies with regulatory and ISO requirements related to the plant, customer specifications, and corporate quality policies. Responsible for implementing the Quality Management System (QMS) and reporting areas of concern to Management.

Key Accountabilities

• Implementation and oversight of a Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance
• Document control and review / approval of controlled documents
• Change management and review of all change controls
• Supplier quality management and performance of supplier audits as appropriate
• Complaint management including robust root cause analysis and CAPA
• Internal Audit Program
• Training Program
• Validation Master Plans including equipment, process, product, sterilization and test methods
• Quality control laboratory and review / approval of QC testing
• Cleanroom practices including qualification, monitoring and behavior
• Quality Risk Management

Supports the Global QMS e-tool (MQ1) implementation, plus the WW QMS Manager, in development and deployment of policies and procedures.

Performs Quality Review of batch documentation and testing and determines disposition for all production batches and incoming raw materials.

Customer Management

Facilitates Management Review process and the metrics control plan to measure the health of the QMS, Manufacturing System, and Supply Chain.

Qualifications

Education

Experience

Benefits

About Us

Saint-Gobain's Life Sciences division develops high-performance polymer products and solutions for life sciences applications. We are a Global 500 corporation that values innovation, respect, and collaboration to improve lives.

Equal Opportunity Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.

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