Quality Assurance Manager

Role Overview

• Leads their own specific tasks and responsibilities within a team, prioritizing time and effort towards important deliverables and producing high-quality work.
• Contributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own skills.
• Influences, partners and collaborates with other colleagues within and outside their team.
• 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.
• Activities may include GCP audits of investigator sites, 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.
• Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices (COs) processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as policies, procedures and industry standards.
• The QAS should have a comprehensive working knowledge of Quality Assurance, regulations and auditing.
• Develops and delivers awareness sessions with minimal supervision on various GCP and PV topics internally and externally.
• Promotes standardization of auditing approach within QA.
• Routinely suggests new audit techniques/aids in areas of technical expertise.
• Ensures the work climate/culture within QA, exemplifies the Leadership behaviors.

Requirements

• BS/BA degree or above in Clinical Medicine, life science or pharmacy.
• Clinical development knowledge system, capabilities in multiple therapeutic areas or GxP quality management, and In-depth clinical regulations insight and expertise.
• Clinical audit or quality management or inspection management experience is preferred.
• Diverse working experience, including different stages of clinical research, and/or working in MNC is a plus.

Tech Stack

• Google Cloud Platform

Benefits

• Not Applicable