Temporary Manager, R&D Quality

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.; Ciudad de México; Hybrid; MXN 560,000 - 1,040,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

14 weeks parental leave

Job summary

Novartis Farmacéutica S.A. de C.V. seeks a QMS & Compliance Manager to lead BR strategy for GxP procedures, training, and document management. You will partner with global stakeholders to ensure a compliant quality system that meets regulatory requirements.

You will oversee BR Quality training, document control, audits, CAPAs, and KPIs, while coordinating cross-functional BR activities and audits to ensure continuous improvement.

Qualifications

• Bachelor's degree in a scientific or business discipline.
• Fluency in English (oral and written).
• 7+ years of experience in a scientific/biotech/pharma industry, preferably in a GxP QA or compliance role.
• 5 years of experience in a GxP quality management system (GLP/GCP preferred).
• Experience with SOP creation and change control.
• Ability to deliver results with minimal supervision.
• Experience planning and conducting quality management system audits.
• Ability to work in a matrix, cross-functional global setting.

Responsibilities

• Lead BR strategy and governance for GxP procedures, training, and document management.
• Represent BR at governance boards for procedures and training.
• Manage BR Quality’s training program and content development.
• Develop and deputize BRQ participation in cross-functional DMS councils.
• Coordinate BR Quality team meetings and access controls.
• Support inspection and audit activities and regulatory document preparation.
• Ensure auditable documentation per Novartis standards.

Skills

English fluency

GxP QA experience

Audit management

SOP creation

Regulatory compliance

Quality systems

Cross-functional work

MS Office

Communication

Travel readiness

Education

Bachelor's degree in science or business

Job description

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.

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 review outcomes/trends to sustain improvement and ensure timely escalation when required.
• Support inspection and audit activities, including generation and compilation of regulatory-relevant documents.
• Collect, store, and maintain all auditable documentation per Novartis internal standards.
• Execute assigned activities within the Audit management system.
• Support BR Quality team with planning and reconciliation of actions.
• Coordinate BR Quality team meetings such as Global Team Meeting and Speaker presentations.
• Manage BR Quality shared drive access, Group Management Tool distribution lists, mailboxes, organizational charts and PersiLog.

Minimum Requirements

• Bachelor's degree in a scientific or business discipline.
• Fluency in English (oral and written). Additional languages are a plus.
• 7+ years’ experience in a scientific/biotech/ pharmaceutical industry, preferably in a GxP QA or compliance role.
• 5 years of practical experience in a GxP quality management system (experience with GLP and GCP preferred).
• Experience with Standard Operating Procedure 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.
• Demonstrated ability to work successfully within a matrix environment and influence cross-functional teams in a global setting.
• Excellent written and verbal communication.
• Strong Microsoft office skills (e.g. MS Word, Excel, PowerPoint).
• Demonstrated ability to prioritize competing business priorities and effectively manage projects and resources in a fast paced/high volume environment.
• The candidate may be required to travel (domestic and international).

Benefits & Rewards

• Expected Annual Base Salary Range for role: 560,000.00 - 1,040,000.00 MXN Annual
• Base salary is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and is reviewed periodically upon joining.
• In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
• We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.
• Flexible and hybrid working options, where possible.
• Minimum 14 weeks paid parental leave.
• Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
• Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable.

Accessibility and accommodation

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

• Collaboration
• Communication
• Corrective and Preventive Action (CAPA)
• Data Integrity
• Good Manufacturing Practices (GMP)
• Inspection Management System
• Operational Excellence
• Performance Auditing
• Problem Solving
• Quality Assurance (QA)
• Quality Compliance
• Quality Management
• Quality Management Systems (QMS)
• Regulatory Compliance
• Stakeholder Management
• Standard Operating Procedure (SOP)