Saint-Gobain Performance Plastics
Plant Quality Manager - Manufacturing, Life Sciences; Clearwater, FL
Saint-Gobain Performance Plastics, Clearwater, Florida, United States, 34623
Plant Quality Manager - Manufacturing, Life Sciences; Clearwater, FL
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Plant Quality Manager - Manufacturing, Life Sciences; Clearwater, FL
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Saint-Gobain Performance Plastics 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
Ensure robust and effective corrective action to customer audit observations Review/approve Quality Agreements with customers Partner in the resolution of Quality Issues and requests for information by initiating effective interdepartmental communication Manage ISO Certification & Maintenance Facilitates Management Review process and the metrics control plan to measure the health of the QMS, Manufacturing System, and Supply Chain. Qualifications
Education Bachelor's Degree - Life Sciences related field (i.e. Chemistry, Biology, Microbiology), Engineering or Related Field; Required Master's Degree - Engineering or Business; Preferred Experience 8+ years of Life Sciences experience in regulated industry (i.e. Pharma, Biopharma, Medical Devices, etc.) 6+ years of progressive manufacturing experience within Quality Management 3+ years of experience in Quality System design, development and implementation 3+ years of supervisory experience Ability to travel upwards of 20% to sister sites and/or training Benefits
Health and Wellbeing – Medical, Vision, Dental Insurance 401(k) with Company Match and retirement plans Paid Time Off and Paid Parental Leave Employee Assistance Program (EAP) Life Insurance, Short-Term Disability, Disability coverages Voluntary Life Insurance options and additional benefits Back-up Child & Elder Care, Identity Theft Protection, and other voluntary 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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Join to apply for the
Plant Quality Manager - Manufacturing, Life Sciences; Clearwater, FL
role at
Saint-Gobain Performance Plastics 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
Ensure robust and effective corrective action to customer audit observations Review/approve Quality Agreements with customers Partner in the resolution of Quality Issues and requests for information by initiating effective interdepartmental communication Manage ISO Certification & Maintenance Facilitates Management Review process and the metrics control plan to measure the health of the QMS, Manufacturing System, and Supply Chain. Qualifications
Education Bachelor's Degree - Life Sciences related field (i.e. Chemistry, Biology, Microbiology), Engineering or Related Field; Required Master's Degree - Engineering or Business; Preferred Experience 8+ years of Life Sciences experience in regulated industry (i.e. Pharma, Biopharma, Medical Devices, etc.) 6+ years of progressive manufacturing experience within Quality Management 3+ years of experience in Quality System design, development and implementation 3+ years of supervisory experience Ability to travel upwards of 20% to sister sites and/or training Benefits
Health and Wellbeing – Medical, Vision, Dental Insurance 401(k) with Company Match and retirement plans Paid Time Off and Paid Parental Leave Employee Assistance Program (EAP) Life Insurance, Short-Term Disability, Disability coverages Voluntary Life Insurance options and additional benefits Back-up Child & Elder Care, Identity Theft Protection, and other voluntary 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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