Haleon Life Sciences Jobs – Apply For Quality Manager
Quality & Oversight Manager
India – Andra Pradesh – Hyderabad
Time Type: Full time
Posted on: Posted Today
Job Requisition ID: 518770
Position Purpose
Drive implementation of quality management strategy within Clinical Development, Consumer Safety and Regulatory. Ensure oversight of quality management system by the leadership team including QPPV and Process Excellence & Quality Director. Develop and maintain a Center of expertise around quality management activities (e.g., deviation, continuous improvement, change control) to ensure ongoing alignment of quality-related goals and strategy and to achieve having a ONE R&D team. Support with Regulatory Intelligence implementation for Clinical Development, and Consumer Safety.
Accountabilities/Responsibilities
- Be center of expertise (CoE) for quality management related activities and ensure integration & standardisation of business processes and best practice sharing across the matrix organization (Regulatory, Clinical Development and Consumer Safety)
- Implement consistent process for documentation & escalation of deviations & associated CAPAs
- Ensure collection & collation of data for leadership oversight (including QPPV and Process Excellence & Quality Director) e.g., dashboards, summary reports, etc.
- Provide technical and operational support for quality activities and deliverables including deviation and Corrective Actions Preventative Actions (CAPA) management, group mailbox triage, risk assessment facilitation, document archival, teamsite and website maintenance (including access management) and act as subject matter expert on Veeva Quality Management System
- Coordinating regulatory intelligence monitoring and support impact assessment and process implementation to meet regulatory requirements
- May act as process owner for regulatory intelligence as well as product intelligence and associated safety notification
- Support Haleon QPPV as required including but not limited to i) input to PSMF ii) collection & collation of data for QPPV oversight (e.g., dashboards, summary reports, etc.) iii) coordination of QPPV Office activities
- May coordinate governance bodies (process governance/ oversight governance)
Qualifications
BS Degree in Life Sciences, Quality, Pharmacovigilance or equivalent
Competencies and Skills
- Demonstrated experience in the pharmaceutical industry, with a minimum of 3 years in pharmacovigilance
- Knowledge of global pharmacovigilance, cosmetovigilance, materiovigilance and nutrivigilance regulations, guidelines, guidances, and best practices is required. Knowledge of clinical development is a plus
- Understanding of Root Cause Analysis and establishing effective corrective and preventative actions
- Ability to manage and co-ordinate tasks, projects, and processes across the department and across the organization
- Ability to recognize key issues/gaps, quickly develop insight into underlying issues and propose practical strategies
- Effective communication skills
- Ability to work effectively/collaboratively cross-culturally and cross-functionally
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