Quality and Risk Management Lead
7 days ago
We are seeking a seasoned Quality and Risk Management Lead to join our team at GSK. This is an exciting opportunity for a professional with a strong background in pharmaceutical/vaccines industry experience, quality- and risk management-related areas, and proven leadership skills.
Key ResponsibilitiesThe successful candidate will lead Root Cause Analysis for cross-functional issues and critical risks, coordinate CAPA management, develop training materials, and implement process improvements. Key responsibilities include:
- Leading Root Cause Analysis for cross-functional issues and critical risks via dedicated Root Cause Investigator.
- Coordinating cross-functional CAPA management and advising on CAPA effectiveness checks.
- Overseeing the CAPA closure and effectiveness implementation.
- Developing training material and training business on risk management, root cause investigations, and SMART CAPAs.
- Contributing to the development, continuous improvement, and successful implementation of a simplified and effective process aligned with the GSK Quality Management System.
- Working with relevant stakeholders to improve our understanding of challenges and associated solutions to ensure excellence in issue management.
- Acting as first-line support to assist business areas navigate and discharge responsibilities relating to the process, as well as addressing concerns or questions.
- Partnering with Clinical Development Quality Assurance and business partners to create and operationalize robust issue management processes that support the organization in fostering a high-quality culture.
- Using key performance indicators to monitor performance of adoption and implementation of the process.
To be successful in this role, you will need:
- A Bachelor's Degree, preferably in a scientific discipline.
- Broad and robust pharmaceutical/vaccines industry background and experience in R&D, with a proven record of projects successfully led in a matrix environment, including problem-solving, self-discipline, and operating under pressure.
- Proven record of robust experience in quality- and risk management-related areas, including root cause analysis and the ability to drive pragmatic, data-driven decisions.
- Proven record of the ability to drive performance and influence stakeholders; proven record of change management, streamlining, and learning agility.
- Proven record of implementing the Internal Control Framework (ICF) and, in particular, Risk Management and Management Monitoring ICF elements, in a naive population, with successful outcomes.
- Expertise in essential regulatory guidelines worldwide, as well as GSK company policies and procedures.
The estimated salary range for this role is between $120,000 and $180,000 per annum, depending on location and experience.
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