Regional Quality Lead - Compliance - QM - SOPS - CRA

Regional Quality Lead - Compliance - QM - SOPS - CRA

Job deliverables/Job description

Provide quarterly listings of planned On-Site Quality Monitoring Visits (OSQMV; source "QCAT") versus planned (interim) DBL in collaboration with Data Analytics

Perform 6-monthly reconciliation of OSQMV versus QCAT (oversee process compliance)

Lead/coordinate analysis of OSQMV and local Trial Master File checks and generate regular reports for LL

Coordinate review of audit/inspection findings to identify areas of risk for GCO

Lead OSQMV and local TMF process enhancements such as simplified OSQMV report, incorporating into Metricstream

Liaise with BRQC metrics team and other stakeholders to prepare for and issue quarterly LOC compliance metrics (kQPIs)

Oversee follow-up actions for LOC metrics with rQ experience with data management

Must have an eye for detail

Communication skills: Persuasive, good conflict handling and negotiation skills

Good command of English.

Under minimal direction act as the liaison between R&D Quality Processes and the Regional Q&C function in Global Clinical Operations (GCO) to facilite the roll out and implementation of the Janssen R&D quality management strategy across EMEA, Americas and APAC in a streamlined and seamless manner.

Provide strategic support to Director, Regional QM&C, as well as compliance support to Regional Q&C and partner organizations.

Coordinate, in close collaboration with internal partners, the compilation of Local Operating Company (LOC) clinical operation quality performance indicators and issue local GCO compliance reports.

Complement the Therapeutic Area metrics review, by providing input from the local GCO metrics reports.

Provide guidance and consultancy to the Regional Q&C function in close partnership with members of R&D Q&C to ensure local/regional remediation actions are performed to ensure a continued state of inspection readiness.

In close collaboration with Regulatory Compliance, support the oversight of the process to capture changes in local regulatory requirements and the evaluation of their impact on local and global clinical operations processes and procedural documents.

Coordinate and/or support special projects to address global compliance and risk remediation needs.

Work with GCO regional Q&C and business partners to ensure central repositories with country intelligence are kept up to date.

Works in a collaborative manner with business partners to create a team environment that addresses compliance-related issues that meet the business needs on an on-going basis.