Abilash Jilla
Director, Clinical Quality Assurance, Merck Research Labs at Merck | Infectious Disease and Vaccines
- Role
- Director, Clinical Quality Assurance, Merck Research Labs at Merck Infectious Disease and Vaccines at Merck
- Location
- Hampton, NJ, US
- LinkedIn followers
- 500 followers
About Abilash Jilla
GCP Clinical Quality Assurance Auditor with 13 years of extensive experience in…
Experience
Director, Clinical Quality Assurance, Merck Research Labs at Merck Infectious Disease and Vaccines
Jun 2024 — Present · Rahway, NJ, US
Ensure implementation and management of the Quality Assurance (QA) strategy in Infectious Disease | Vaccine Therapeutic Area (TA) across multiple programs, indications and/or regions- Ensure QA principles are considered throughout the drug development process, risk mitigation strategies for programs underway are implemented and quality metrics, including audits, are utilized to inform the business of the state of quality of the programs within the ID | Vaccine space- Utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of Clinical Trials, quality and integrity of generated data, and the rights and welfare of study participants- Perform risk assessments to identify audit targets, conduct audits, develop and maintain audit tools, as well as review audit reports- Assure quality standards are consistently applied and will escalate resource and data quality matters to Senior Management as appropriate- Maintain robust audit and quality oversight plans for aligned ID | Vaccine TA, contribute to the QA strategy and through collaboration with stakeholders, R&D Division\'s QA TA Heads, refine and adjust strategies and plans as needed- Lead and manage range of GCP audits, including complex audits (i.e, directed, for-cause), for a given program, across a program, TA or region- Interface with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide guidance on GCP and QA expertise.
Education
New Jersey City University
BS, Biology
2004 — 2008
Rutgers School of Public Health
MPH, Epidemiology
2009 — 2012
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