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.

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, 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).

This role is a temporary role for 6 months.

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: 560,000.00 - 1,040,000.00 MXN Annual

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. 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. In addition, we provide flexible and hybrid working options, where possible, and 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. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

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 tas.mexico@novartis.com 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)