Job Description Summary
LI-Hybrid
Location: Mexico
Temporary role for 6 months
This role is based in Insurgentes , Mexico. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.
The QMS & Compliance Manager, BR will be responsible for leading the BR strategy and governance for GxP procedures, training, and document management. The role will partner with internal group and functional-level business and quality stakeholders to provide an appropriate quality management system to meet Novartis and regulatory requirements.
The role will also be responsible for supporting and executing the BR compliance program oversight.
Job Description
Major Accountabilities:
• Support the BR Procedure and Training strategy, including oversight of SOP creation, access, change control and training. Represent BR at applicable group and functional level procedure and training governance boards.
• Manage BR Quality’s training program, including infrastructure, content development, delivery and liaising with the Up4Growth Learning Center.
• Contribute to the BR document management system (DMS) strategy and deputize for BRQ participation on cross-functional DMS councils and workstreams.
• Actively participate in cross functional process review to ensure alignment with BR requirements
• Provide QMS guidance to BR Quality and Business functions regarding issues related to health authority expectations/regulations, data integrity, quality systems/issues, Novartis Standards and BR’s Quality Module (QM) creation, revision, and implementation. Conduct QM gap assessments in collaboration with stakeholders.
• Oversee and execute the compliance program oversight including tracking, monitoring, and reporting of BR KQIs: inspections, audits, CAPAs, assessments, and compliance activities. Proactively reviewing outcomes/trends to sustain improvement and ensuring timely escalation when required.
• Support inspection and audit activities, i