Sr. Specialist, Quality Assurance
Pubblicato il 18-09-2026 - Merck Sharp & Dohme (MSD) in Lazio
Job Description
Our Research & Development Division QA Clinical Quality (CQ) provide independent assurance that our Company ensures the safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and strategies for ensuring data integrity in our clinical trials.
Primary Responsibilities
Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
Be able to analyze and leverage critical to quality factors to identify potential risks to prepare and perform risked-based audits
Applies data-driven approaches, including the use of analytics dashboards and quality metrics, to detect trends, prioritize audit focus areas, enhance risk-based decision making, and deliver value-added insights that support continuous quality improvement.
Influences,
partners and collaborates with other colleagues within and outside their team Activities may include GCP audits of investigator sites, study level, suppliers, third party collaborations and due diligence activities.
In alignment with risk assessments, supports the QAL in the identification of audit substrate for scheduling, as appropriate.
Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.
Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.
Travel
Travel 50% - 70%
Skills
- Ownership and Accountability - Taking ownership; setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing s