Independent Consultant
Current
Self-Employed
Nov 2011 - Present
AeroLeads people directory · profile
Susan M. Smith Email & Phone Number
Quality Systems Consultant | Change Controls, Deviations, CAPAs | Vendor Management | Auditing Program | Guidance documents (SOPs, POLs, WIs) | Training Program | EDMS Configuration | MasterControl | Veeva | ZenQMS
at
Self-employed
1 work email found
@replimune.com
LinkedIn matched
4 data sources
Profile completeness 100%
Current company
Self-employed
Role
Quality Systems Consultant | Change Controls, Deviations, CAPAs | Vendor Management | Auditing Program | Guidance documents (SOPs, POLs, WIs) | Training Program | EDMS Configuration | MasterControl | Veeva | ZenQMS
Location
North Andover, Massachusetts, United States
Who is Susan M. Smith? Overview
A concise factual answer block for searchers comparing this professional profile.
Quick answer
Susan M. Smith is listed as Quality Systems Consultant | Change Controls, Deviations, CAPAs | Vendor Management | Auditing Program | Guidance documents (SOPs, POLs, WIs) | Training Program | EDMS Configuration | MasterControl | Veeva | ZenQMS at Self-employed, based in North Andover, Massachusetts, United States. AeroLeads shows a work email signal at replimune.com and a matched LinkedIn profile for Susan M. Smith.
Susan M. Smith previously worked as Independent Consultant at Self-Employed and Quality Systems Consultant at The Q (Consulting Company) - Clinical Stage Oncology. Susan M. Smith holds Associate'S Degree, Business Administration And Management, General from American Intercontinental University.
Company email context
Email format at Self-employed
This section adds company-level context without repeating Susan M. Smith's masked contact details.
*@replimune.com
68% confidence
AeroLeads found 1 current-domain work email signal for Susan M. Smith. Compare company email patterns before reaching out.
Profile bio
About Susan M. Smith
With over ten years of quality systems consulting experience, I help life sciences companies optimize their quality operations and mitigate risks. As a MasterControl System Administrator, I manage the document management, training, deviations, change controls, and CAPAs processes for the company. I also have experience in Veeva and ZenQMS.I support the implementation and maintenance of quality management systems, ensuring compliance with regulatory requirements and industry standards. I have strong analytical, interpersonal, and communication skills, and I work cross-functionally to resolve issues and identify gaps. My goal is to provide quality solutions that enhance the performance and efficiency of the quality systems.
Listed skills include Quality Assurance, Cross Functional Team Leadership, Pharmaceutical Industry, Biotechnology, and 45 others.
Current workplace
Susan M. Smith's current company
Company context helps verify the profile and gives searchers a useful next step.
Self-Employed
11 roles
Susan M. Smith work experience
A career timeline built from the work history available for this profile.
Quality Systems Consultant
Current
The Q (Consulting Company) - Clinical Stage Oncology
Training ProgramSOP DevelopmentInternal Audit
Dec 2023 - Present
Quality Systems Consultant - Mastercontrol System Administrator
Conjugate Consulting - Pieris Pharmaceuticals
Quality System DevelopmentMasterControl System AdministratorMaster Control Implementation (Process Module)
Oct 2020 - Jan 2024
Director Quality Systems
➢ Document Management➢ Training➢ Change Control➢ Deviation Management➢ CAPAs➢ Vendor Management➢ Quality Metrics Reporting and Trending
Dec 2018 - Oct 2020
Quality Systems Consultant
Feb 2018 - Dec 2018
Quality Systems Consultant
2018 – 2018 Agilis BioTherapeutics2018 – 2018 Replimune2017 – 2018 Tesaro, Waltham, MA2017 – 2018 Affiinivax2017 – 2017 Aegerion, Cambridge, MA2016 – 2017 Seres, Cambridge, MA2016 – 2016 Keryx, Boston, MA2013 – 2016 Agios, Cambridge, MA2013 – 2013 Alnylam, Cambridge, MA2011 – 2012 Biogen, Cambridge, MA
Nov 2011 - 2018
Quality Systems Project Manager/Technical Writer (Consultant)
- Developing and implementing GxP Quality Systems.
- Developed paper-based Documentation system
- Developed and Managed Training Program
- SharePoint Design and maintenance
- Coordinating GxP SOP Project - Facilitating teams to revise and develop new SOPs
- Audit Management
Sep 2013 - Apr 2016
Quality System Consultant (Qa Project Planning/Technical Writer)
Managed project to re-level SOPs and Work Instructions: Developed and managed project plan; facilitated meetings with cross-functional management/groups to review, revise, process map and identify process improvements for functional procedures..
Feb 2012 - Mar 2013
Business Planning Manager (Wyeth Biotech)
- Managed the Quality Agreement program for the Andover Site (including microbiology co-testing agreements).
- Led global biotech team to gain alignment on quality agreement program and strategy.
- Identified and implemented continuous improvement project to streamline and utilize electronic workflows.
Feb 1999 - Jul 2011
Business Planning Manager (Wyeth Biotech)
- Coordinated/Supported Quality leadership with the following:
- Annual operating and capital budget.
- Salary planning.
- Goals, objectives and key performance indicators.
- Headcount and organizational data
- Developed and implemented projects (cross functional teams):
Feb 2005 - Feb 2009
Senior Business Analyst (Wyeth Biotech)
Feb 2002 - Feb 2005
1 education record
Susan M. Smith education
-
American Intercontinental University
FAQ
Frequently asked questions about Susan M. Smith
Quick answers generated from the profile data available on this page.
What company does Susan M. Smith work for?
Susan M. Smith works for Self-employed.
What is Susan M. Smith's role at Self-employed?
Susan M. Smith is listed as Quality Systems Consultant | Change Controls, Deviations, CAPAs | Vendor Management | Auditing Program | Guidance documents (SOPs, POLs, WIs) | Training Program | EDMS Configuration | MasterControl | Veeva | ZenQMS at Self-employed.
What is Susan M. Smith's email address?
AeroLeads has found 1 work email signal at @replimune.com for Susan M. Smith at Self-employed.
Where is Susan M. Smith based?
Susan M. Smith is based in North Andover, Massachusetts, United States while working with Self-employed.
What companies has Susan M. Smith worked for?
Susan M. Smith has worked for Self-Employed, The Q (Consulting Company) - Clinical Stage Oncology, Conjugate Consulting - Pieris Pharmaceuticals, Replimune, Inc., and Various Companies.
How can I contact Susan M. Smith?
You can use AeroLeads to view verified contact signals for Susan M. Smith at Self-employed, including work email, phone, and LinkedIn data when available.
What schools did Susan M. Smith attend?
Susan M. Smith holds Associate'S Degree, Business Administration And Management, General from American Intercontinental University.
What skills is Susan M. Smith known for?
Susan M. Smith is listed with skills including Quality Assurance, Cross Functional Team Leadership, Pharmaceutical Industry, Biotechnology, Business Planning, Project Management, Gmp, and Quality System.
Find 750M verified contacts
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trial