SANTIAGO NORIEGA
Leominster,MA
Summary
Over 25 years’ experience in implementation and maintenance of Quality Systems such as ISO 9001, ISO 13485, ISO 14001, IATF 16949 and GMP in plants in Canada, China, Germany, Mexico, Singapore and the US. Worked extensively to develop a team-oriented environment across all corporate departments: Marketing, Finance, Research & Development, Engineering, Manufacturing, Planning, Purchasing, Quality and Sales, in order to maximize the use of resources to improve designs, manufacturing processes, supplier performance, and cost improvements.
Overview
18
18
years of professional experience
1
1
Certification
Work History
site manager
Sanofi
02.2022 - Current
- Client facing senior on-, for the, and Northborough, sites
- Manage facilities operations, GMP cleaning, custodial, equipment maintenance (HVAC, electrical, etc) operations of building(s) and property, landscaping, grounds, planning & scheduling, lab services and calibration
- Responsible for achieving site specific KPIs for Safety, Quality, Cost and Productivity: 2022 KPI Average 96.2%
- Defining, implementing, and revising operational policies and guidelines for the organization
- Developing and executing new growth directives
- Keeping track of the company’s revenue margins and conducting periodic budget reviews to maximize profits.
DIRECTOR
FACILITIES
03.2020 - Current
SR. QUALITY/HSE MANAGER
03.2020 - 02.2022
- Lead group Quality/HSE functions in achieving departmental goals supporting the Sanofi Pharmaceutical Company account
- Assure customer requirements are met
- Oversee P&S, LDM & HVAC team activities to assure team achieves departmental goals and meet customer expectations
- Provide subject matter technical expertise to team in areas of strategic planning, change management, and business process improvement
- Led project that successfully improved supplier rating from 3 to 2, which allows Sodexo to provide GxP services to Sanofi worldwide
- Led project that developed $6.3 Million GxP sanitization solution proposal for cleanrooms with estimated savings of over $500K from previous provider
- Contract awarded to Sodexo, transitioned on January 1st, 2022.
OWNER/QUALITY CONSULTANT
06.2019 - 03.2020
- Provide independent, objective advice to organizations on strategies to improve the quality of their products and services
- Perform Quality Management System audits of customer sites and systems, provide detailed reports listing: gaps, strengths and recommendation for system changes as needed
- Facilitate Strategic Plan development (1-Year Plan, 3-Year Picture, 10-Year Target) and SWOT Analysis (Strengths, Weaknesses Opportunities, Threats)
- Train customer’s personnel on how to map out a process to identify gaps, perform root cause analysis (RCA), Kaizen events, eight disciplines (8D) problem solving, 5-Whys, Fishbone Diagram, Failure Mode and Effects Analysis (FMEA), Control Plans (CP), Production Part Approval Process (PPAP).
05.2018 - 05.2019
- Led the QA & CI staff across five facilities operating in the United States, Germany, China and Singapore
- As a member of the Senior Leadership Team, I developed the company’s global quality strategy to ensure continued double-digit growth year after year
- Championed and built a high performing Quality & Continuous Improvement Culture throughout the corporation
- Selected, developed and evaluated personnel to ensure the efficient operation of the function
- Implemented Automotive Quality Management System IATF 16949:2016 in the Singapore plant
- Initiated project hopper for the corporation: team identified over 70 projects totaling potential savings of $1.2 Million Dollars
- 8 Projects closed in 2018 and 3 in 2019
- Lead project to upgrade document control, change control and training systems from manual processes to a Web based software (MasterControl).
SR. DIRECTOR OF GLOBAL QUALITY & CONTINUOUS IMPROVEMENT
DYMAX CORPORATION
09.2016 - 05.2019
DIRECTOR OF GLOBAL QUALITY
09.2016 - 05.2018
- Led the QA staff in 2 Plants in the US, 1 Plant in China, 1 Plant in Germany, 1 Plant in Singapore
- Successful transition of all manufacturing plants from ISO 9001:2008 to ISO 9001:2015
- Developed a centralized customer complaint/feedback and resolution (CFR) program for the corporation to address customer complaints in a timely manner and identify trends
- Customer returns reduced by 69% in 2018 from 2017
- First Pass Yield Improvement Worldwide from 92.9% in 2016, 94.6% in 2018 by:
- Implementing a robust Corrective & Preventive Action (CAPA) system
- Updating procedures and Bills of Materials correctly to eliminate tribal knowledge
- Enforced the use of Design of Experiments (DOE) by R&D and manufacturing to optimize products/process
- Implemented Risk management process: used the system to address top Risk products, this led to changes in specification, design or obsolescence of the products.
QUALITY ASSURANCE MANAGER
04.2011 - 09.2016
- Manufacturer of Pharmaceutical, Food & Service, High Purity Electronic Filters and ASME Pressure Vessels
- Led group quality function in achieving departmental goals & assured customer requirements were met
- Managed compliance to ISO 9001:2008 & ISO 13485:2016 (Pharmaceutical Products)
- Managed supplier development program: scorecard for top 10 critical suppliers
- 3M PI Global Customer Complaint and Supplier Management Databases Administrator: develop training, train personnel
- Led six sigma SKU Rationalization project for the Process Hardware Group which resulted in the reduction of 4,412-part numbers (approx
- 60% of product portfolio), which improved manufacturing efficiency through reduction of changeovers.
3M PURIFICATION INC
03.2005 - 09.2016
Education
Master of Business Administration -
University of Hartford
Master of Engineering - undefined
University of Hartford
BS - Mechanical Engineering Technology
Northeastern University
Skills
- Proficient in
- Microsoft Office (Excel/Word/PowerPoint/Visio), Project, Minitab, SolidWorks
- Familiar with Oracle's JD Edwards EnterpriseOne and SAP ERP (Enterprise resource planning)
- Santiago Noriega Page 2 of 3
Certification
Six Sigma Green Belt by 3M
Languages
English
Full Professional
Spanish
Full Professional
Timeline
site manager
Sanofi
02.2022 - Current
DIRECTOR
FACILITIES
03.2020 - Current
SR. QUALITY/HSE MANAGER
03.2020 - 02.2022
OWNER/QUALITY CONSULTANT
06.2019 - 03.2020
05.2018 - 05.2019
SR. DIRECTOR OF GLOBAL QUALITY & CONTINUOUS IMPROVEMENT
DYMAX CORPORATION
09.2016 - 05.2019
DIRECTOR OF GLOBAL QUALITY
09.2016 - 05.2018
QUALITY ASSURANCE MANAGER
04.2011 - 09.2016
3M PURIFICATION INC
03.2005 - 09.2016
Master of Business Administration -
University of Hartford
Master of Engineering - undefined
University of Hartford
BS - Mechanical Engineering Technology
Northeastern University
Six Sigma Green Belt by 3M
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