Cynthia Pleach is a high-skilled professional, working in Ironwood Pharmaceuticals main office of which is in 518. on the position of Senior Manager, Quality Systems since 2011. Cynthia has earned professional experience in more than seven positions at different companies. Cynthia Pleach went to the Boston College and got education from 1981 to 1984. Westboro, Massachusetts is the area, where this person was lastly known to live. Cynthia's phone and email can be accessed through this website on demand.
Name variants:
Cindy Pleach,
Cyndi Pleach
Last updated Apr 30, 2024
Contact Information
Workplace
Senior Manager, Quality Systems
Cambridge, MA
Industry
Pharmaceuticals, Professional, Scientific and Techincal Servies, Scientific Research and Development Services, Commercial Physical Research Business Services, Pharmaceutical Preparations and Commercial Physical Research
Colleagues
Work History
Contractor in Quality and Regulatory group
Working in the UAT group writing acceptance test scripts for Clarify feedback tracking software.
Oct 2010 — Dec 2011
Business Systems Analyst III
Designed the QMS Workflows for Deviation, Investigation, CAPA, OOS, OOT, MAR, MRB, NCM resulting in the on time release of the SmartCapa module and improved Quality Metrics.
Designed the Aud...
Apr 2005 — Jul 2009
Quality Systems Engineer
• Led cross functional team in evaluating software to change QMS data collection from manual to electronic in compliance with Part 11 requirements.
• Wrote user requirement ...
2002 — 2005
Senior Engineer, Corporate Quality
QUALITY MANAGEMENT SYSTEM DEVELOPMENT
• Led engineering effort to document processes for ISO9001:2000 compliance and developed metrics for engineering which resulted in obtaining ISO...
2000 — 2001
Homologation Manager
• Developed and documented the homologation process by consolidating the work into one group from multiple groups. This resulted in the products being approved in North and South Am...
1995 — 2000
Quality Systems Engineer
Senior Quality Engineer (90-94), Compliance Engineer (86-90), Quality Systems Analyst (84-86)
QUALITY MANAGEMENT
• Performed Quality Engineering function for Intelligent Switching Hub wor...
1981 — 1994
Education
1981 — 1984
Occupations
Executive
Senior Manager
Contractor
Operations Manager
Independent Business Owners
Skills
Business Process Development
Release Management
Technical Support
Team Building
21 CFR Part 11
Cross-functional Team Leadership
Design Control
Quality System
Computer System Validation
Change Control
Process Improvement
GAMP
Validation
CAPA
Medical Devices
Continuous Improvement
FDA
Software Documentation
Quality Management
Document Management
ISO 13485
Root Cause Analysis
ISO 14971
GxP
Quality Assurance
Quality Control
Manufacturing
FAQs about Cynthia Pleach
What's the main profession of Cynthia Pleach?
This professional's job is Senior Manager, Quality Systems
What are the profession of Cynthia?
These person's professions are Executive and Senior Manager
Where does Cynthia Pleach live?
Westboro, Massachusetts is the place where Cynthia Pleach currently lives
Where did Cynthia Pleach work?
The professional worked at Ironwood Pharmaceuticals, Philips Healthcare.
Where has Cynthia Pleach studied?
Cynthia studied at the Boston College from 1981 to 1984.
What is professional industry that Cynthia Pleach is connected to?
Cynthia Pleach works in Pharmaceuticals industry.
What are the skills of Cynthia Pleach?
This professional has skills in the following areas: Business Process Development, Release Management, Technical Support, Team Building, 21 CFR Part 11, Cross-functional Team Leadership, and Design Control.