Plant Quality Manager Manufacturing, Life Sciences Bioprocess

1 month ago

Al Khobar Eastern Province Saudi Arabia Saint-Gobain Performance Plastics Full time
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're one of only two companies in the world that is consistently recognized as both a top Global Employer and a Top 100 Global Innovator, but Saint-Gobain's remarkable story and 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 will be accountable to ensure the Quality Management System is implemented per requirements and to report areas of concern to Management. The Plant Quality Manager will be expected to ensure the plant remains in full compliance with regulatory requirements and ISO requirements as they pertain to the plant, customer specifications, and corporate quality policies.

The Plant Quality Manager implements and oversees the Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including:

Implementation of document control and review/approval of controlled documents Implementation of change management and review of all change controls Implementation of supplier quality management and performance of supplier audits as appropriate - Complaint management including robust root cause analysis and CAPA Implementation of an effective Internal Audit Program - Ensure adequate Training Program is in place Implementation of applicable Validation Master Plans including equipment, process, product, sterilization and test methods Implementation/oversight of quality control laboratory and review/approval of QC testing Oversight of cleanroom practices including qualification, monitoring and behavior Implementation of Quality Risk Management in relevant aspects of the QMS Responsible for implementation of the Global QMS e-tool (MQ1) at the plant and serving as mentor to other plants in FLS for implementation. Support the WW QMS Manager in development and deployment policies and procedures for elements of the global QMS.

The Plant Quality Manager performs Quality Review of batch documentation and testing and determines disposition for all production batches and incoming raw materials. They ensure robust root cause analysis investigation and CAPA for deviations and nonconforming product.

The Plant Quality Manager manages Customer Management, including: Facilitating/hosting customer audits. They ensure robust and effective corrective action to customer audit observations.

They review/approve Quality Agreements with customers as well as partner in the resolution of Quality Issues and requests for information by initiating effective interdepartmental communication. They manage ISO Certification & Maintenance of certification.

The Plant Quality Manager facilitates the Management Review process including implementation of a metrics control plan to measure and monitor the health of the Quality Management System, Manufacturing System, and Supply Chain.

The Plant Quality Manager executes talent management activates with direct reports, if applicable. They ensure proper performance management, training, and development of direct reports as well as others duties as assigned.

QUALIFICATIONS The Plant Quality Manager abides by strict adherence and a commitment carrying out the Corporate and/or local policies, rules, and regulations in these areas is required. An employee in this position must focus on customers' expectations and strive for continuous improvement resulting in improved results for themselves, customers, and other employees.

Education: Bachelor of Science Degree: Life Sciences or Engineering (Chemistry, Biology, or Microbiology), Required. Master of Science: Life Sciences or Engineering, Preferred

Experience Life Sciences experience in regulated industry (pharma, biopharma or medical device); 8 or more years, Required Quality function experience; 6 or more years, Required Experience in Quality system design, development and implementation; 3 or more years, Required Supervisory Experience; 3 or more years, Required

WHO WE ARE:

Saint-Gobain Research (SGR) North America is one of Saint-Gobain's largest industrial research laboratories. The center is home to more than 400 employees working at the leading edge of innovation on multidisciplinary industrial research, preparing the future by designing tomorrow's products and processes across an amazing variety of markets and technical disciplines. Since 1985, SGR North America has been supporting existing businesses, developing future businesses, and nurturing talent.

Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in many industrial applications. They provide comfort, performance and safety while addressing the challenges of sustainable construction, resource efficiency and climate change.

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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