Denise Ruby work email
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Denise Ruby personal email
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.
Astellas Pharma Us
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Head Of Pharmacovigilance QaAstellas Pharma Us May 2023 - Present
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Senior Director, Clinical Quality AssuranceAstellas Pharma Us Oct 2020 - May 2023
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Director, Clinical Quality AssuranceAstellas Pharma Us Jul 2020 - Oct 2020
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Senior Director, Clinical Quality AssuranceTakeda Aug 2016 - Sep 2019Tokyo, JpLed 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 the facilitator during inspections. -
Director, Clinical Quality AssuranceTakeda Mar 2013 - Aug 2016Tokyo, JpProvided 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.
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Associate Director, Clinical Quality AssuranceTakeda Sep 2012 - Mar 2013Tokyo, JpDirected 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.
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Interim Director, Clinical Quality AssuranxeTakeda Feb 2012 - Sep 2012Tokyo, JpManaged 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.
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Senior Manager, Clinical Qa OperationsTakeda Jul 2008 - Feb 2012Tokyo, JpLed 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.
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Assistant Director/Project Manager, Research Quality AssuranceTap Pharmaceuticals Mar 2007 - Jul 2008UsOversaw 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. -
Clinical Trial ManagerTap Pharmaceuticals Dec 2003 - Mar 2006UsManaged 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.
Denise Ruby Skills
Denise Ruby Education Details
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Temple University School Of PharmacyRegulatory Affairs And Quality Assurance -
Barat College Of Depaul UniversityGeneral
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Lake Forest Graduate School Of ManagementGeneral
Frequently Asked Questions about Denise Ruby
What company does Denise Ruby work for?
Denise Ruby works for Astellas Pharma Us
What is Denise Ruby's role at the current company?
Denise Ruby's current role is Head of Pharmacovigilance QA @ Astellas Pharma US | Registered Quality Assurance Professional-GCP.
What is Denise Ruby's email address?
Denise Ruby's email address is dr****@****keda.us
What schools did Denise Ruby attend?
Denise Ruby attended Temple University School Of Pharmacy, Barat College Of Depaul University, Lake Forest Graduate School Of Management.
What skills is Denise Ruby known for?
Denise Ruby has skills like Gcp, Pharmaceutical Industry, Edc, 21 Cfr Part 11, Sop, Clinical Research, Oncology, Pharmacovigilance, Therapeutic Areas, Clinical Development, Ctms, Fda.
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