Local Quality Responsible

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The Position

The Opportunity

Roche Pharma in Midrand is seeking a Local Quality Responsible (LQR) to join their team.

You as a LQR are a strategic quality partner of the Country Medical Director (CMD) and Affiliate business.

You are responsible for implementing the Affiliate Quality Management System (QMS) and ensuring local Medical Compliance-related activities are delivered.

LQRs provide support to the CMD in maintaining the affiliate  License to Operate (LTO) and are accountable for medical compliance reporting and inspection readiness, in alignment with local regulations and global standards.

Key Challenges

Quality System Administration


* Lead the implementation of the global Roche QMS at the affiliate level to meet regulatory requirements.


* Drive the implementation of the global and local Quality strategies, objectives, and initiatives as applicable.


* Drive and enable the overall CAPA management process at the local level (self-identified deviations, audits, and inspection findings), and proactively identify related trends and risks, to lead continuous improvement.


* Drive and implement the local training process for QMS activities, and ensure that an aligned local training strategy is in place.


* Drive the local implementation of QMS procedural document lifecycle management.


* Proactively monitor and oversee external regulatory changes affecting affiliate QMS in alliance with process owners and ensure that the local regulatory requirements are implemented, as per the Regulatory Intelligence Process.


* Partner with the Affiliate COREMAP representative to implement the records management requirements for QMS in accordance with the Roche Global Records Management Directive.

Medical Compliance and Risk Management
 

1.

Lead Affiliate Medical Compliance Oversight as per Affiliate Medical Compliance Oversight Process


* Lead the process to measure the overall Affiliate Medical Compliance status and take necessary actions.


* Define and oversee local metrics.

In collaboration with functional SMEs, as required, ensure adequate metrics are in place to assure compliance.


* Lead the Affiliate Management Review (MRs) and Affiliate Medical Compliance Office (AMCO,) ensuring that key outputs are understood by senior management and appropriate decisions and actions are taken where necessary.


* Contribute to the continuous improvement of the global QMS by providing Affiliate insights through SIRIUS.


* Ensure key insights on QMS h...