Temporary QMS & Compliance Manager, R&D (GxP)

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

Benefits offered by this job

Insurance plans

Hybrid working options

Parental leave

Job summary

Novartis Mexico in Insurgentes is seeking a Temporary Manager, R&D Quality to lead BR strategy, governance for GxP procedures, training, and document management. The role collaborates with group and quality stakeholders to build a compliant QMS.

This six-month assignment requires a scientific or business degree, fluent English, and 7+ years in biotech/pharma with GxP QA experience. Hybrid work supported; MXN salary disclosed.

Qualifications

• Bachelor’s degree in a scientific or business discipline.
• Fluency in English (oral and written).
• 7+ years in a scientific/biotech/pharmaceutical industry, preferably in a GxP QA or compliance role.
• 5 years in a GxP quality management system (GLP/GCP preferred).
• Experience with SOP creation, compliance activities and change control.
• Ability to work with minimal guidance or supervision.
• Experience in planning, conducting and managing quality system audits.
• Ability to influence cross-functional teams in a global matrix.
• Strong MS Office skills and effective communication.
• Willingness to travel domestically and internationally.

Responsibilities

• Lead BR strategy and governance for GxP procedures, training and document management.
• Represent BR at group and functional procedure and training governance boards.
• Manage BR Quality’s training program, including content development and delivery.
• Contribute to the BR DMS strategy and cross-functional councils.
• Provide QMS guidance on health authority expectations and Novartis standards.
• Oversee and execute BR compliance program oversight including KPIs, inspections and CAPAs.
• Support inspection and audit activities with auditable documentation.
• Coordinate BR Quality team meetings and manage shared drives and distributions.

Skills

Fluent English

Cross-functional collaboration

Education

Bachelor's degree in a scientific or business discipline

Tools

MS Office

Job description

Novartis Mexico in Insurgentes is seeking a Temporary Manager, R&D Quality to lead BR strategy, governance for GxP procedures, training, and document management. The role collaborates with group and quality stakeholders to build a compliant QMS.

This six-month assignment requires a scientific or business degree, fluent English, and 7+ years in biotech/pharma with GxP QA experience. Hybrid work supported; MXN salary disclosed.