If you want to 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 Multi-Site Plant Quality Manager will ensure the effective implementation of the Quality Management System in alignment with regulatory and corporate requirements across Two manufacturing locations:- Beaverton, MI and Williamsburg, MI..-
Will proactively identify and report areas of concern to management while driving compliance with ISO 13485, customer specifications, and corporate quality procedures. Will be the point of contact for customer quality escalations.
Will develop and implement consistent quality systems across to enhance operational efficiency and support strategic initiatives as guided by the BPS Quality Director. Will lead, train, and develop quality teams at multiple locations, fostering a culture of continuous improvement.
Essential Functions:
Implementation and oversight of a Quality Management System that operates in compliance with corporate quality policies and procedures, as well as relevant regulatory requirements (ISO:13485) and industry guidance.
Oversee and manage Quality department personnel at each site, including Quality Lab, Supplier Quality, Quality Engineering, and Focus Factory Quality Engineers.
Develop and implement consistent quality systems across all sites to enhance operational efficiency.
Support the BPS Director of Quality in development and deployment of policies and procedures for elements of the global QMS.
Support strategic initiatives as guided by the BPS Director of Quality.
Promote and enforce a safe working environment, including proper use of PPE and active participation in department safety meetings.
Investigate and report incidents while ensuring compliance with Environmental Management System (EMS) requirements and best environmental practices.
Implementation of document control and review/approval of controlled documents.
Implementation of ECO process including 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.
Ensure robust root cause analysis investigation and CAPA for deviations and nonconforming product.
Implementation of effective Internal Audit Program.
Ensure adequate training program is in place.
Implementation of an applicable Validation Master Plan including equipment, process, product, sterilization and test methods.
Oversight of cleanroom practices including qualification, monitoring, and behavior.
Implementation of Quality Risk Management in relevant aspects of the QMS.
Maintenance of the Global QMS e-tool (ETQ) at the plant.
Execute talent management activities with direct reports. Ensure proper performance management, training, and development of direct reports.
Customer Management including facilitate/host customer audits, ensure timely, robust and effective corrective action to customer audit observations, review/approve quality agreements with customers, partner in the resolution of quality issues and requests.-
Critical Events and complaint management
Bachelor's Degree in Life Sciences related field (Chemistry, Biology, Microbiology), Engineering, Quality, Operations Management or other applicable degree with Life Sciences experience; required.
10+ years of experience in a Quality function in Quality System design, development, implementation role or progressive roles held in an operations site; required.
8+ years of experience in a regulated industry with preferred emphasis in life sciences (e.g., pharma, biopharm, or medical device); required.
5+ years of direct supervisory experience.
Strong knowledge of ISO (ISO 13485 specifically required) and cGMP requirements and relevant industry standard practices is required. Must have the ability to interpret these regulations to ensure proper implementation in the plant systems; required.
We provide unique options to fit your unique lives! Our Total Rewards Program is customizable to accommodate your needs. Our menu of flexible options (https://bit.ly/2RZtfYI) includes, but is not limited to:
Excellent healthcare options: Medical, vision, prescription & dental
Family Focus & Balance: Parental leave, paid time-off and Employee Assistance Program
Financial Security: Competitive 401(k), Company-funded Retirement Accumulation Plan and Employee Stock Purchase Program (PEG)
Tuition Reimbursement: Continuing education for every season of your career
Pet Insurance options: Insurance plan & prescription discount program for your furry friends
Employee Recognition Programs
PerkSpot: Our exclusive one-stop online discount marketplace
LiveWell: Rewarding you for living a healthy lifestyle
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.
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Join Us at Saint-Gobain Life Sciences. Together, we'll create a better life.
Click here to Explore more opportunities within Saint-Gobain Life Sciences. (https://careers.saint-gobain-northamerica.com/career-search/?pg=1&search=Life%20Sciences)
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.
