The Quality Management Lead GCP is responsible for implementing the "pro-active quality principles" throughout the Clinical Development organization by providing continuous support and input during the Clinical Development Activities in the GCP area. The Quality Management Lead is also involved in the management of the GCP procedural documents (ProcDocs) i.e. in the creation, review, approval, distribution, revision and obsoletion of the GCP ProcDocs.
- Build GCP compliance awareness throughout the Clinical Development organization:
- Build and maintain strong cross-functional collaborative working relationships. Assist in driving change to build a culture of quality compliance throughout the Clinical Development organization.
- Provide continuous quality compliance support by acting as an internal advisor on relevant processes, procedural documents and regulations to ensure correct interpretation and implementation.
- Mitigate quality compliance risks.
- Act as a point of contact for any quality related questions, concerns.
- Escalate quality / compliance / privacy issues and support investigation.
- Collaborate to audit and inspection activities:
- Collaborate with the Quality Assurance Lead giving input for the creation and maintenance of audit programs.
- Assist the business stakeholders to ensure proper CAPA formulation and timely CAPA implementation and follow-up.
- Conduct, reporting and follow-up of vendor QA qualification assessments.
- Lead / contribute to Regulatory Authority Inspections.
- Identify areas for improvement based on Quality Management activities and audit / inspection outcome.
- Support effective implementation of the QMS-ProcDocs in the GCP organization:
- Develop procedural documents in line with GxP and with the Quality Manual, in collaboration with the business stakeholders. Contribute to the creation of new procedural documents, as well as to the revision of procedural documents.
- Conduct procedural documents review and approval activities.
- Follow-up on procedural documents distribution and training activities.
- Follow-up on procedural documents lifecycle.
- Participate in and collaborate to continuous improvement initiatives.
- Support in training activities i.e. process training, new regulations training, new systems training, etc.
- Adherence to existing Policies and Procedures and ensure timely completion of relevant training.