Quality Capability and Risk Associate at GSK

Quality Capability & Risk Associate

The purpose of the Quality, Capability & Risk Associate (QCRA) role is to support the regional in-country QCRM team to ensure that clinical research activities are conducted by local/regional Clinical Operations staff in accordance to ICH GCP, relevant international and local regulations, requirements and guidelines, as well as GSK written standards.

Key Responsabilities

• Support the in-country QCRMs in the region with quality-related topics to ensure that clinical research activities are conducted according to ICH GCP, local legislation and GSK written standards.
• Support the development and maintenance of local plans/documentation and systems (Risk Register, Management Monitoring and Training Plan) to ensure that:
• All risks are properly managed, documented and escalated as appropriate within GSK.
• All aspects of management monitoring (MM) activities are delivered in partnership with the local Clinical Operations team, including identification and delivery of MM-related CAPAs.
• Local staff are appropriate trained to conduct their roles.
• Support issue management activities, including issue identification, resolution and escalation across all studies and local Clinical Operations teams.
• Support the implementation of ongoing quality improvement processes, including those identified during management monitoring and issue management activities.
• Support local training needs, in collaboration with the in-country QCRM, Capability Building team and local Clinical Operations Leadership Team.
• Support the in-country QCRMs to foster a quality culture and support delivery of upper quartile performance.
• Support the in-country QCRMs as the local ambassador for the global Quality, Capability and Risk Management organization.
• Work across local and regional teams to share best practices and collaborate with QCRMs and other QCRAs on ways of working.

Education Required

Scientific Degree or equivalent experience ideally with some quality experience (Any science degree - e.g. life sciences, medicine, clinical research, pharmacy etc. ).

Basic Qualifications/Experience

• 3 years’ experience in Clinical Operations. Knowledge of the drug development processes and key operational interfaces.
• Good understanding of clinical/corporate governance principles
• Knowledge of ICH GCP requirements with knowledge of local and global regulatory requirements applying to Clinical Trials.
• Good written and verbal communication skills in English.
• Fluent in local language if required.
• Advanced user of MS Office (PowerPoint, Excel, Word & Outlook)

Other Skills

• Understanding of clinical research and the drug development process.
• Can work both independently on projects and also part of a team.
• Creative, logical, strategic thinker
• Effective problem solver and conflict resolution
• Good eye for detail and high learning agility
• Knowledge of ICH GCP / IND guidelines
• Knowledge of global and local GSK written standards.
• Understanding of the Internal Control Framework
• Act as a role model in line with GSK values and behaviors
• Collaborative and open leadership style