Plant Quality Manager - Bioprocess Solutions
Company: Saint-Gobain Performance Plastics
Posted on: January 16, 2022
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
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
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
Implementation of supplier quality management and performance of
supplier audits as appropriate
Complaint management including robust root cause analysis and
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
Responsible for implementation of the Global QMS e-tool (MQ1) at
the plant and serving as mentor to other plants for
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
Review/approve Quality Agreements with customers
Partner in the resolution of Quality Issues and requests for
information by initiating effective interdepartmental
Manage ISO Certification & Maintenance of certification.
Facilitate 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
Lead, coach and mentor the Quality team responsible for ensuring
high quality integrity of all products/process within the plant.
Execute talent management activities, ensuring proper performance
management, training and employee development with team members
Develop both strategic and tactical plans for quality culture
development for facility
Help drive Quality and Process Control Pillar for 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
Must have experience in performing risk analysis (e.g. FMEA, FTA,
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
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.
Keywords: Saint-Gobain Performance Plastics, Madison , Plant Quality Manager - Bioprocess Solutions, Executive , Portage, Wisconsin
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