Head Of Pharmacovigilance Qa
Current
Astellas Pharma Us
May 2023 - Present
AeroLeads people directory · profile
Denise Ruby Email & Phone Number
Head of Pharmacovigilance QA @ Astellas Pharma US | Registered Quality Assurance Professional-GCP
at
Astellas Pharma US
1 work email found
@astellas.com
LinkedIn matched
✓ Verified Jun 2026
4 data sources
Profile completeness 100%
Current company
Astellas Pharma US
Role
Head of Pharmacovigilance QA @ Astellas Pharma US | Registered Quality Assurance Professional-GCP
Location
Greater Chicago Area, United States, United States
Who is Denise Ruby? Overview
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Quick answer
Denise Ruby is listed as Head of Pharmacovigilance QA @ Astellas Pharma US | Registered Quality Assurance Professional-GCP at Astellas Pharma US, based in Greater Chicago Area, United States, United States. AeroLeads shows a work email signal at astellas.com and a matched LinkedIn profile for Denise Ruby.
Denise Ruby previously worked as Head of Pharmacovigilance QA at Astellas Pharma Us and Senior Director, Clinical Quality Assurance at Astellas Pharma Us. Denise Ruby holds Certificate In Drug Development, Regulatory Affairs And Quality Assurance from Temple University School Of Pharmacy.
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{first}.{last}@astellas.com
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Profile bio
About Denise Ruby
I am an analytical and strategic clinical leader with extensive experience supporting the development of GCP-related quality system SOPs in compliance with applicable regulatory requirements and best industry practice.The majority of my career has been in Quality Assurance and Clinical Operations roles of increasing responsibility and scope, providing direct management and support of clinical trials in multiple therapeutic areas in Phase 1 through Phase 4 clinical drug development. In addition to providing strategic solutions in the GCP arena, my core competencies include R&D, audit management, quality investigations and CAPA, clinical operations, talent management and the preparation and facilitation of sponsor and investigator site GCP and PV inspections for FDA and MHRA.
Listed skills include Gcp, Pharmaceutical Industry, Edc, 21 Cfr Part 11, and 32 others.
Current workplace
Denise Ruby's current company
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Astellas Pharma Us
10 roles
Denise Ruby work experience
A career timeline built from the work history available for this profile.
Senior Director, Clinical Quality Assurance
Astellas Pharma Us
Oct 2020 - May 2023
Director, Clinical Quality Assurance
Astellas Pharma Us
Jul 2020 - Oct 2020
Senior Director, Clinical Quality Assurance
Led the Americas and Europe Clinical Quality Assurance function in providing quality oversight of clinical development activities for global development programs. Managed a team of 15-18 quality professionals in a global setting. Provided direct support of FDA and MHRA sponsor inspections, providing strategic guidance to the internal teams and serving as.
Aug 2016 - Sep 2019
Director, Clinical Quality Assurance
Provided leadership to the Takeda Clinical QA function to ensure investigator, GCP vendor, and submission document audits were conducted to support development programs. Provided oversight of quality investigations, leading complex investigations and served as a senior strategic GCP resource to Takeda for its drug development activities.
Mar 2013 - Aug 2016
Associate Director, Clinical Quality Assurance
Directed the Clinical QA Program Managers ensuring that investigator, vendor, document and system audits were conducted and reported in accordance with Takeda requirements. Provided direct supervision for up to 6 Program Managers including staff selection, work assignments, goal completion, development plan review and completion of performance reviews.
Sep 2012 - Mar 2013
Interim Director, Clinical Quality Assuranxe
Managed CQA and Pharmacovigilance function for the Americas region to ensure the development and implementation of strategies for quality oversight, including the execution of audits and investigations.
Feb 2012 - Sep 2012
Senior Manager, Clinical Qa Operations
Led the US CQA Operations function ensuring all US, Canada and Latin America clinical trial activities were conducted in compliance with GCP requirements. Provided direct supervision of up to 6 Program Managers.
Jul 2008 - Feb 2012
Assistant Director/Project Manager, Research Quality Assurance
Oversaw the activities of the RQA Associate Project Managers. Developed and implemented risk-based audit plans for multiple studies. Provided compound support and served as a quality resource to R&D, including developing and presenting on GCP, data on common audit and inspection findings.
Mar 2007 - Jul 2008
Clinical Trial Manager
Managed Phase 3 clinical research trials including oversight of contract research vendor contracts totaling $18 million. Led NDA and study timeline management and coordinating cross-functional efforts to achieve project objectives and goals. Managed and directed the activities for up to 4 direct reports.
Dec 2003 - Mar 2006
3 education records
Denise Ruby education
Certificate In Drug Development, Regulatory Affairs And Quality Assurance
Temple University School Of Pharmacy
Bachelor'S Degree, Business Administration And Management, General
Barat College Of Depaul University
Master Of Business Administration - Mba, Business Administration And Management, General
Lake Forest Graduate School Of Management
FAQ
Frequently asked questions about Denise Ruby
Quick answers generated from the profile data available on this page.
What company does Denise Ruby work for?
Denise Ruby works for Astellas Pharma US.
What is Denise Ruby's role at Astellas Pharma US?
Denise Ruby is listed as Head of Pharmacovigilance QA @ Astellas Pharma US | Registered Quality Assurance Professional-GCP at Astellas Pharma US.
What is Denise Ruby's email address?
AeroLeads has found 1 work email signal at @astellas.com for Denise Ruby at Astellas Pharma US.
Where is Denise Ruby based?
Denise Ruby is based in Greater Chicago Area, United States, United States while working with Astellas Pharma US.
What companies has Denise Ruby worked for?
Denise Ruby has worked for Astellas Pharma Us, Takeda, and Tap Pharmaceuticals.
How can I contact Denise Ruby?
You can use AeroLeads to view verified contact signals for Denise Ruby at Astellas Pharma US, including work email, phone, and LinkedIn data when available.
What schools did Denise Ruby attend?
Denise Ruby holds Certificate In Drug Development, Regulatory Affairs And Quality Assurance from Temple University School Of Pharmacy.
What skills is Denise Ruby known for?
Denise Ruby is listed with skills including Gcp, Pharmaceutical Industry, Edc, 21 Cfr Part 11, Sop, Clinical Research, Oncology, and Pharmacovigilance.
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