Research Quality Director
CurrentDriving risk-based quality assurance for pre-clinical research, including GLP-regulated activities, quality oversight of GLP vendors/suppliers, and GLP inspection readiness/ management.
May 2024 - Present
AeroLeads people directory · profile
Lisa Hernandez Email & Phone Number
Director, Research Quality
at
Amgen
1 work email found
@medtronic.com
LinkedIn matched
✓ Verified July 2026
4 data sources
Profile completeness 100%
Current company
Role
Director, Research Quality
Location
New York City Metropolitan Area, United States
Who is Lisa Hernandez? Overview
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Quick answer
Lisa Hernandez is listed as Director, Research Quality at Amgen, based in New York City Metropolitan Area, United States. AeroLeads shows a work email signal at medtronic.com and a matched LinkedIn profile for Lisa Hernandez.
Lisa Hernandez previously worked as Research Quality Director at Amgen and Director, Quality Compliance Combination Product Quality at Amgen. Lisa Hernandez holds Bachelor'S Degree, Chemistry from Saint Anselm College.
Company email context
Email format at Amgen
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{first}.{last}@medtronic.com
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AeroLeads found 1 current-domain work email signal for Lisa Hernandez. Compare company email patterns before reaching out.
Profile bio
About Lisa Hernandez
Accomplished professional with 25+ years of pharmaceutical, combination product and medical device experience with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. Dynamic leader adept in coaching, training, and mentoring staff with a global mindset for driving diversity and inclusion in the workplace. Proven ability to manage crises and resolve emergency planning utilizing cross-functional communication and partnership. Recognized key contributor in the establishment, implementation, and compliance assessment of quality standards.Established foundation in Analytical Chemistry and expertise in writing technical documents across the product lifecycle. Strong ability to interface with colleagues and customers at a technical as well as conceptual basis.
Listed skills include Pharmaceutical Industry, Hplc, Drug Discovery, Drug Development, and 24 others.
Current workplace
Lisa Hernandez's current company
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6 roles
Lisa Hernandez work experience
A career timeline built from the work history available for this profile.
Director, Quality Compliance Combination Product Quality
Direct the Combination Product Quality Compliance organization advancing the overall compliance for Amgen’s combination products globally through implementation of industry best practices, effective Health Authority interactions and excellence in audit/inspection execution.
Nov 2021 - May 2024
Director Customer Quality Experience Management - Medical Surgical Portfolio
Led the Medical Surgical Portfolio including 6 business units providing strategic oversight in the areas of post market surveillance, complaint handling, regulatory reporting, inspection execution and Health Authority interactions for Medtronic medical devices worldwide.
Feb 2021 - Nov 2021
Director Post Market Vigilance - Quality Assurance
Led Medical Surgical Portfolio covering six business units providing strategic oversight related to post market surveillance, complaint handling, regulatory reporting, inspection execution and Health Authority interactions for Medical Surgical devices worldwide. Supervised Bio-Hazard laboratories and operations, ensuring safety and reliability of Medical Surgical products for patients worldwide. Initiated measures and process improvements that improved overall KPI metrics. Directed global regulatory inspections such as MDSAP while serving as liaison between business and competent authorities to conduct inquiry reviews and issue related responses. Ensured adherence to local and international regulatory authorities pertaining to medical device and vigilance reporting, as well as CFR, GxP, ISO, EU MDR, and other applicable regulations.
Dec 2016 - Feb 2021
Senior Associate Director, Medical Technical Customer Information
Local Pharmaceutical Complaint officer (LPCO): Directed a group of six direct reports responsible for technical product complaints and inquiries reported throughout the US market by ensuring the quality processing and handling of these complaints in accordance with FDA, and corporate regulations while reporting all related adverse events to Global Pharmacovigilance.
May 2014 - Nov 2016
Principal Scientist, Research And Development
Direct a GMP drug product development laboratory providing both early and late-stage development support for multiple formulation development compounds simultaneously covering method development and validation, GLP toxicology studies, clinical and development out of specification investigations, software validation, impurity analyses, drug product characterization and release/stability testing.
Dec 1995 - May 2014
Team & coworkers
Colleagues at Amgen
Other employees you can reach at amgen.com. View company contacts →
CO
Chika Okoro, E.I.T., Cmvp-It
Colleague at AmgenLos Angeles, California, United States
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PM
Pawel M.
Colleague at AmgenCraigavon, Northern Ireland, United Kingdom
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RM
Ryan Michaels
Colleague at AmgenWarwick, Rhode Island, United States
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WJ
Wen Jie Yang
Colleague at AmgenWest Greenwich, Rhode Island, United States
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LG
Leandro Gentini
Colleague at AmgenUnited States
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MM
Miguel Moreno
Colleague at AmgenPuerto Rico
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RC
Rodrigo Coelho
Colleague at AmgenLisbon Metropolitan Area, Portugal
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DA
Dasha Applewhite, Bs, Pacs
Colleague at AmgenUnited States
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AM
Anda Mateescu (Ilie)
Colleague at AmgenBucharest, Romania
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HZ
Hao Zhang
Colleague at AmgenGreater Boston, United States
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Chika Okoro, E.I.T., Cmvp-It
Colleague at AmgenLos Angeles, California, United States
View →
PM
Pawel M.
Colleague at AmgenCraigavon, Northern Ireland, United Kingdom
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RM
Ryan Michaels
Colleague at AmgenWarwick, Rhode Island, United States
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WJ
Wen Jie Yang
Colleague at AmgenWest Greenwich, Rhode Island, United States
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LG
Leandro Gentini
Colleague at AmgenUnited States
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MM
Miguel Moreno
Colleague at AmgenPuerto Rico
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RC
Rodrigo Coelho
Colleague at AmgenLisbon Metropolitan Area, Portugal
View →
DA
Dasha Applewhite, Bs, Pacs
Colleague at AmgenUnited States
View →
AM
Anda Mateescu (Ilie)
Colleague at AmgenBucharest, Romania
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HZ
Hao Zhang
Colleague at AmgenGreater Boston, United States
View →
2 education records
Lisa Hernandez education
Bachelor'S Degree, Chemistry
Saint Anselm College
Master'S Degree, Analytical Chemistry
University Of New Hampshire
FAQ
Frequently asked questions about Lisa Hernandez
Quick answers generated from the profile data available on this page.
What company does Lisa Hernandez work for?
Lisa Hernandez works for Amgen.
What is Lisa Hernandez's role at Amgen?
Lisa Hernandez is listed as Director, Research Quality at Amgen.
What is Lisa Hernandez's email address?
AeroLeads has found 1 work email signal at @medtronic.com for Lisa Hernandez at Amgen.
Where is Lisa Hernandez based?
Lisa Hernandez is based in New York City Metropolitan Area, United States while working with Amgen.
What companies has Lisa Hernandez worked for?
Lisa Hernandez has worked for Amgen, Medtronic, and Boehringer Ingelheim.
Who are Lisa Hernandez's colleagues at Amgen?
Lisa Hernandez's colleagues at Amgen include Chika Okoro, E.I.T., Cmvp-It, Pawel M., Ryan Michaels, Wen Jie Yang, and Leandro Gentini.
How can I contact Lisa Hernandez?
You can use AeroLeads to view verified contact signals for Lisa Hernandez at Amgen, including work email, phone, and LinkedIn data when available.
What schools did Lisa Hernandez attend?
Lisa Hernandez holds Bachelor'S Degree, Chemistry from Saint Anselm College.
What skills is Lisa Hernandez known for?
Lisa Hernandez is listed with skills including Pharmaceutical Industry, Hplc, Drug Discovery, Drug Development, Glp, Life Sciences, Sop, and Analytical Chemistry.
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