WHY DO WE NEED YOU?
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'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 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 (see below) and to 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.
IS THIS JOB FOR YOU?
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.
TO MAKE SURE NOTHING IS FORGOTTEN
Employees have the flexibility to choose the benefits that best fit their individual needs.
- Health and Wellbeing – Supporting your wellbeing, to thrive in life and work.
- 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 - Helping to make the future life you want a reality.
- 401(k) with Company Match, Retirement Accumulation Plan (RAP), Cash Balance Pension Plan
- Company-provided Life Insurance, AD&D, Short-Term Disability
- Voluntary employee and dependent life insurance, Long-Term Disability, Critical Illness and Accident Insurance
- Additional Benefits – Helping shape the experience and impact you want
- Commuter Benefits
- Group Legal
- Identity Theft Protection
- Auto and Home Insurance
- Pet Insurance and Discounts
- Back-up Child & Elder Care
- PerkSpot Employee Discount Program
A LITTLE MORE ABOUT US
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.
Click here to Explore more opportunities within Saint-Gobain Life Sciences.
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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.
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.