Our client is a global leader having recently completed a major restructuring of its Quality organisation, resulting in a number of new opportunities to impact the function at global level.
The Quality Compliance Lead will be the person responsible for all activities related to regulatory authority inspection as well as associated inspection readiness activities.
This role spans the biologics portfolio, with internal and external manufacturing partners.
- Ensure inspection readiness activities are carried out at internal and external supply sites including reporting, identification and mitigation of inspection risks, development of risk and mitigation action plans
- Host external Biologics inspections both locally and at external supply locations (or ensure appropriate co-hosts are identified & trained)
- Ensure inspection responses are appropriately managed including responses, CAPA planning etc
- Maintain Site Master Files as well as site licenses, renewals and inspection documentation
- Manager the Quality Counsel for external supply
- Broadly experienced quality professional, conversant in DP, DS, fill & package for biologics or aseptic processing.
- Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and other Regulations.
- Strong technical, interpersonal, communication and leadership skills.
- Strong organizational and thinking skills.
- Degree in a scientific/technical discipline - additional function-specific qualifications advantageous