Quality & Compliance Manager
Stevenage / Remote
The key purpose of this role is to ensure the safety of all GSK Clinical Trial participants, patients, and consumers administered or using GSK products, by supporting the successful collection, processing and reporting of safety data of GSK products globally.
This role ensures that case management activities align with GSK standards for processing human safety information (HSI) and that regulatory requirements, including timelines are achieved. This is done by driving the implementation of robust processes and training for successful performance of case management activities, including PV vendor oversight mechanisms.
The job holder provides relevant oversight to the PV Ops Directors and drives the understanding of case management requirements across all business units.
· Input into Root Cause Analysis (RCA) and corrective/preventive action (CAPA) formation/effectiveness checks
· Ensures appropriate reporting activities are complete, as per Regulatory requirements
· Ensures that changes to Regulations are assessed for impact and any necessary changes are implemented, also providing awareness to QPPV Office.
· Support risk assessment and management of risk registers
· Supports Inspections/Audits (led by PVQA of Central/LOC/Vendor processes)/ LP Audits/ Regulatory Inspections (Central and LOC)/ Notified Body Audits
· Ensures appropriate management monitoring activities are complete
· Where problems or issues are identified, ensures appropriate escalation and resolution
· Works across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements
· Where process or training issues are identified, facilitates investigation into root cause, creation of corrective/preventative actions (CAPAs), and supports with remediation of process/training needs
· Manages mailboxes for responsible workstream and responds to allocated queries in a timely and professional manner
· Identifies changes to regulations that may impact CMG activities, assesses impact, coordinates implementation of changes and tracks change.
· Tracks and oversees regulatory enquiries sent to CMG, ensuring appropriate, thorough and timely responses
· Coordinates appropriate archiving, in line with GSK Global Archiving processes, ensuring the successful retrieval of documentation and supporting inspection-readiness
· Generates new ideas and proposals for global implementation; contributes to advancement of methodology and optimization of processes.
· Demonstrates GSK values during interactions
Essential Core skills
· Degree in life sciences or medically-related field or previous experience equating to educational requirements
· Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements
· Working knowledge of principles of data collection, manipulation and retrieval and experience summarizing data
· In-depth understanding of medical and drug terminology
· Proven experience of prioritisation and time management
· Strong communication skills
· In-depth knowledge of safety databases strongly preferred
· Solution-driven and proactive way of working
Desirable skills and experience
· Knowledge of GSK products and business structure
· Project management experience
· Ability to map processes and author written standards
· Knowledge and experience with pharmacovigilance systems
If you feel you would be suitable for the role, please apply with your most up-to-date CV