Contract QMS & Compliance Manager – 6 Months

Novartis; México; Hybrid; MXN 560,000 - 1,040,000; Full time

Job summary

Novartis Mexico is seeking a QMS & Compliance Manager, BR, to lead BR strategy and governance for GxP procedures, training and document management. You will partner with global groups and BR stakeholders to deliver a compliant quality system that meets regulatory requirements and Novartis standards.

The role requires 7+ years in biotech/pharma QA/compliance, strong SOP and audit experience, and the ability to operate in a matrix, often traveling domestically and internationally.

Qualifications

• Bachelor's degree in a scientific or business discipline.
• Fluency in English (oral and written).
• 7+ years' experience in a scientific/biotech/pharma industry, preferably in a GxP QA or compliance role.
• 5 years of practical experience in a GxP quality management system (GLP/GCP preferred).
• Experience with SOP creation, compliance activities and change control.
• Proven ability to achieve results with minimal guidance or supervision.
• Experience in planning, conducting and managing quality management system audits.
• Ability to work in a matrix environment and influence cross-functional teams globally.
• Excellent written and verbal communication.
• Strong Microsoft Office skills (Word, Excel, PowerPoint).
• Willingness to travel domestically and internationally.

Responsibilities

• Support the BR Procedure and Training strategy, including SOP creation, access control and training governance.
• Manage BR Quality’s training program, including content development and delivery.
• Contribute to BR DMS strategy and cross-functional DMS council participation.
• Participate in cross-functional process reviews to align with BR requirements.
• Provide QMS guidance on regulatory expectations, data integrity and QM implementation.
• Oversee compliance program: track/audit BR KQIs, inspections, CAPAs, assessments.
• Support inspections and audits and compile regulatory documents.
• Execute tasks in the Audit management system and assist BR Quality planning.
• Coordinate BR Quality team meetings and presentations.
• Manage BR Quality shared drive access and organizational tools.

Skills

Fluency in English

Stakeholder management

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor's degree in science or business

Tools

Microsoft Office

Audit management system

Job description

Novartis Mexico is seeking a QMS & Compliance Manager, BR, to lead BR strategy and governance for GxP procedures, training and document management. You will partner with global groups and BR stakeholders to deliver a compliant quality system that meets regulatory requirements and Novartis standards.

The role requires 7+ years in biotech/pharma QA/compliance, strong SOP and audit experience, and the ability to operate in a matrix, often traveling domestically and internationally.