Reference : USA00170
Plant Quality Manager - Bioprocess Solutions
- Technical Production
- United States , Wisconsin , PORTAGE
- Posting date : 12/29/2021
- Technical Production
- United States PORTAGE
- Permanent / Regular
- Posting date : 12/29/2021
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 Quality Manger is responsible for the management, development and maintenance of the Quality Management System (QMS) and the Quality Assurance team for the Portage facility. Through guidance and leadership, the Quality Team supports the product development and manufacturing efforts of the plant, investigates any quality issues relating to raw materials or manufactured products, and drives continuous improvement activities.
This role is responsible for the overall quality education at the plant and ensures our QMS adheres to regulatory and company quality policies, procedures and operating guidelines. This role requires a high degree of general business acumen overall and in the area of Quality. The position leads the Quality activities with strategic and tactical management of new and ongoing projects to improve overall quality efficiencies in order to meet our business and customer needs. Successful Quality management ensures compliance with product quality standards and clean room standards and will enhance our manufacturing processes in order to make sure we have consistent cost improvements.
• 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:
• 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
• Support the Quality team in development and deployment policies and procedures for elements of the global QMS.
• Perform Quality Review of batch documentation and testing and determine disposition for all production batches and incoming raw materials. Ensure robust root cause analysis investigation and CAPA for deviations and nonconforming product.
• Customer Management, including:
• 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 of certification.
• Lead, coach and mentor the Quality team responsible for ensuring high quality integrity of all products/process within the plant.
• Bachelor's Degree in Life Sciences or Engineering is required.
• 7+ years experience in Quality Management within a regulated industry; with preferred emphasis in Life Sciences, Pharma, Biopharm, or Medical Device.
• 5+ years within Managerial or Supervisory Capacity.
• Strong knowledge of ISO and cGMP requirements and relevant industry standard practices is required. Must have ability to interpret these regulations to ensure proper implementation in the plant systems.
• Must have experience in performing risk analysis (e.g. FMEA, FTA, Risk Ranking/Filtering)
• Must be able to lead, manage, and motivate a team through direct management or matrix management.
• Incumbent will interact with senior internal and external personnel on plant processes, projects and investigations and must possess excellent verbal and written communication skills.
Who are we ?
Saint-Gobain’s innovations touch almost every major industry around the world. Within its Life Sciences division, teams are solving critical problems for customers who are getting life-saving medical devices to the frontlines of healthcare, discovering essential medications, and nourishing and connecting the world through consumer, industrial and electronics applications. As one of the world’s leading producers of high-performance polymer products, we improve lives by making simple experiences better and being there in life’s critical moments.
Our team members recognize that we all create the 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. And at the heart of our culture, we’ve learned working together makes good ideas, great ones.
With a legacy dating back more than 350 years, Saint-Gobain offers employees the stability and security of a leading Global 500 corporation while operating like multiple small and agile start-ups, where entrepreneurial spirit, pioneering teamwork, and bold, forward-thinking ideas pave new paths. Every team member is encouraged to develop and leverage their unique expertise and strengths to make the greatest impact on the company and our end users.
At Saint-Gobain, you’re empowered and equipped with countless opportunities and resources for professional development. You will find the support you need to create a vision and roadmap for your career, and make that vision a reality.
Invent yourself at Saint-Gobain Life Sciences; and together, we’ll create a better life.
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.