Saint-Gobain High Performance Solutions - Life Sciences, Composites & Mobility
Plant Quality Manager - Manufacturing, Life Sciences
Saint-Gobain High Performance Solutions - Life Sciences, Composites & Mobility, Clearwater, Florida, United States, 34623
Overview
Plant Quality Manager - Manufacturing Facility, Clearwater/Largo, FL If you want to reshape the world and discover your greatest potential, Saint-Gobain provides one-of-a-kind opportunities for innovative problem solvers. We are one of only two companies in the world that is consistently recognized as both a top Global Employer and a Top 100 Global Innovator. Saint-Gobain’s culture of innovation begins with a team of nearly 200,000 creative, diverse and passionate team members collaborating across the globe. We are committed to our mission to improve lives because, every day, we witness the enormous impact of our efforts on the world around us. The Plant Quality Manager for Saint-Gobain Life Sciences ensures the plant remains in full compliance with regulatory requirements and ISO requirements as they pertain to the plant, customer specifications, and corporate quality policies. Will ensure the Quality Management System is implemented per requirements and report 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, including: 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 Facilitate/host customer audits 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. Performance management, training, and development of direct reports.
Qualifications
REQUIRED: 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, Prescription Drug, Vision, and Dental Insurance; Healthcare Saving Account and Flexible Spending Account options; LiveWell Wellness Program; Employee Assistance Program (EAP); Paid Time Off and Paid Parental Leave Retirement and Protection
- 401(k) with Company Match, Retirement Accumulation Plan (RAP), Cash Balance Pension Plan; Company-provided Life Insurance, AD&D, Short-Term Disability; Voluntary life insurance, Long-Term Disability, Critical Illness and Accident Insurance Additional Benefits
- Commuter Benefits, Group Legal, Identity Theft Protection, Auto and Home Insurance, Pet Insurance and Discounts, Back-up Child & Elder Care, PerkSpot Employee Discount Program
About Us
Saint-Gobain’s innovations touch almost every major industry around the world. Within its Life Sciences division, teams solve critical problems for customers who are delivering life-saving medical devices, medications, and applications across consumer, industrial, and electronics sectors. We are one of the world’s leading producers of high-performance polymer products, and we aim to improve lives by making experiences better in moments that matter. Our team members recognize that we all create an environment for people to succeed, with a culture built on respect, open and honest communication, and honoring our commitments to our customers and each other. With a legacy dating back more than 350 years, Saint-Gobain offers the stability of a Global 500 corporation while operating with entrepreneurial spirit and collaborative teams. Invent yourself at Saint-Gobain Life Sciences; and together, we’ll create a better life. Click here to Explore more opportunities within Saint-Gobain Life Sciences. Click here for more opportunities in
Clearwater, FL .
Legal Statement
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. Saint-Gobain is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.
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Plant Quality Manager - Manufacturing Facility, Clearwater/Largo, FL If you want to reshape the world and discover your greatest potential, Saint-Gobain provides one-of-a-kind opportunities for innovative problem solvers. We are one of only two companies in the world that is consistently recognized as both a top Global Employer and a Top 100 Global Innovator. Saint-Gobain’s culture of innovation begins with a team of nearly 200,000 creative, diverse and passionate team members collaborating across the globe. We are committed to our mission to improve lives because, every day, we witness the enormous impact of our efforts on the world around us. The Plant Quality Manager for Saint-Gobain Life Sciences ensures the plant remains in full compliance with regulatory requirements and ISO requirements as they pertain to the plant, customer specifications, and corporate quality policies. Will ensure the Quality Management System is implemented per requirements and report 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, including: 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 Facilitate/host customer audits 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. Performance management, training, and development of direct reports.
Qualifications
REQUIRED: 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, Prescription Drug, Vision, and Dental Insurance; Healthcare Saving Account and Flexible Spending Account options; LiveWell Wellness Program; Employee Assistance Program (EAP); Paid Time Off and Paid Parental Leave Retirement and Protection
- 401(k) with Company Match, Retirement Accumulation Plan (RAP), Cash Balance Pension Plan; Company-provided Life Insurance, AD&D, Short-Term Disability; Voluntary life insurance, Long-Term Disability, Critical Illness and Accident Insurance Additional Benefits
- Commuter Benefits, Group Legal, Identity Theft Protection, Auto and Home Insurance, Pet Insurance and Discounts, Back-up Child & Elder Care, PerkSpot Employee Discount Program
About Us
Saint-Gobain’s innovations touch almost every major industry around the world. Within its Life Sciences division, teams solve critical problems for customers who are delivering life-saving medical devices, medications, and applications across consumer, industrial, and electronics sectors. We are one of the world’s leading producers of high-performance polymer products, and we aim to improve lives by making experiences better in moments that matter. Our team members recognize that we all create an environment for people to succeed, with a culture built on respect, open and honest communication, and honoring our commitments to our customers and each other. With a legacy dating back more than 350 years, Saint-Gobain offers the stability of a Global 500 corporation while operating with entrepreneurial spirit and collaborative teams. Invent yourself at Saint-Gobain Life Sciences; and together, we’ll create a better life. Click here to Explore more opportunities within Saint-Gobain Life Sciences. Click here for more opportunities in
Clearwater, FL .
Legal Statement
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. Saint-Gobain is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.
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