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Carol Donoho is listed as Senior Clinical QA Manager: Evaluate Risk - Maximize Compliance - Interpret Regulations - Mitigate Non-Compliance at Gilead Sciences, based in San Mateo, California, United States. AeroLeads shows a work email signal at gilead.com and a matched LinkedIn profile for Carol Donoho.
Carol Donoho previously worked as Senior Manager, Regulatory Compliance at Gilead Sciences and Associate Director, Clinical QA / Senior Manager, Clinical QA at Human Genome Sciences. Carol Donoho holds Bachelor Of Science (Bs), Medical Technology from Colby-Sawyer College, New London, Nh.
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AeroLeads found 1 current-domain work email signal for Carol Donoho. Compare company email patterns before reaching out.
Guided clinical QA activities of a drug development program for a lupus therapy product through mid- and late-stage studies. Results included successful sponsor and 8 clinical investigator (CI) FDA inspections, each with either an NAI or VAI classification, and an approved BLA. Evaluated risk in clinical studies for two different Phase III programs; audited to detect non-compliance, mitigated compliance concerns and provided stakeholder feedback. Managed and performed quality audits of clinical investigators, vendors, internal systems and clinical development documents.An insightful, dedicated Clinical QA expert with extensive experience in evaluating risk and interpreting regulatory requirements. Able to assess complex GCP compliance issues and to recommend strategies for maximizing compliance.
Listed skills include Gcp, Fda, Clinical Development, Clinical Trials, and 5 others.
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Foster City, CA, US
Provides proactive GCP oversight and guidance to clinical development functional areas. Manages or leads clinical compliance audits of clinical study contributors such as clinical investigators and CROs/vendors. Fosters a culture of quality by supporting the company core values of integrity, teamwork, accountability and excellence.
Rockville, MD, US
Planned GCP compliance program, leading a staff of two in program execution. Managed preparation, hosting and support for regulatory inspections. Provided proactive GCP oversight and guidance to clinical development functional areas and stakeholder groups.
Rockville, MD, US
Assisted department management with the planning and execution of the GCP compliance program through the conduct of audits and management of a CQA staff member.
Princeton, NJ, US
Planned and conducted GCP audits and provided QA support to clinical development teams.
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Mariana Oliveira
Colleague at Gilead Sciences
Belo Horizonte, Minas Gerais, Brazil, Brazil
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JN
Johnny Nguyen
Colleague at Gilead Sciences
Fountain Valley, California, United States, United States
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JL
Jeff L. Peak
Colleague at Gilead Sciences
Suffield, Connecticut, United States, United States
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Amaya Echevarria
Colleague at Gilead Sciences
Greater Madrid Metropolitan Area, Spain
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AW
Adam Weinstein
Colleague at Gilead Sciences
San Francisco Bay Area, United States
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GS
Gema Serrano Sanchez
Colleague at Gilead Sciences
Greater Madrid Metropolitan Area, Spain
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CA
Chris Anoc
Colleague at Gilead Sciences
San Mateo, California, United States, United States
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AS
Amisha Sachdeva
Colleague at Gilead Sciences
Parsippany, New Jersey, United States, United States
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JP
Jennifer Payne, Bsn, Rn
Colleague at Gilead Sciences
Wake Forest, North Carolina, United States, United States
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JC
Jennifer C.
Colleague at Gilead Sciences
San Mateo, California, United States, United States
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Quick answers generated from the profile data available on this page.
Carol Donoho works for Gilead Sciences.
Carol Donoho is listed as Senior Clinical QA Manager: Evaluate Risk - Maximize Compliance - Interpret Regulations - Mitigate Non-Compliance at Gilead Sciences.
AeroLeads has found 1 work email signal at @gilead.com for Carol Donoho at Gilead Sciences.
Carol Donoho is based in San Mateo, California, United States while working with Gilead Sciences.
Carol Donoho has worked for Gilead Sciences, Human Genome Sciences, and Otsuka Pharmaceutical Companies (U.S.).
Carol Donoho's colleagues at Gilead Sciences include Mariana Oliveira, Johnny Nguyen, Jeff L. Peak, Amaya Echevarria, and Adam Weinstein.
You can use AeroLeads to view verified contact signals for Carol Donoho at Gilead Sciences, including work email, phone, and LinkedIn data when available.
Carol Donoho holds Bachelor Of Science (Bs), Medical Technology from Colby-Sawyer College, New London, Nh.
Carol Donoho is listed with skills including Gcp, Fda, Clinical Development, Clinical Trials, Ich Gcp, Capa, Sop, and Clinical Quality.
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