Temporary Manager, R&D Quality

CDMS; Xico; On-site; MXN 700,000 - 900,000; Full time

Benefits offered by this job

Hybrid/work options

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

14 weeks parental leave

Job summary

Novartis seeks a QMS & Compliance Manager, BR, to lead BR strategy and governance for GxP procedures, training, and document management in Insurgentes, Mexico. This temporary 6-month role partners with global quality stakeholders to ensure regulatory compliance and effective quality systems.

The role will drive BR training, document management, audits, and CAPA oversight, while coordinating with global BR teams and inspections. Fluency in English and 7+ years in GxP QA are required.

Qualifications

• Bachelor's degree in a scientific or business discipline.
• Fluency in English (oral and written).
• 7+ years' experience in a scientific/biotech/pharmaceutical industry, 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 work with minimal supervision and manage audits.

Responsibilities

• Lead BR strategy and governance for GxP procedures, training, and document management.
• Oversee BR quality training program and coordinate with Learning Center.
• Support BR DMS strategy and cross-functional governance.
• Provide QMS guidance on regulatory expectations and data integrity.

Skills

Bachelor's degree

English fluency

GxP QA/compliance

Quality systems audits

Change control

SOP creation

Cross-functional collaboration

Education

Bachelor's degree in science or business

Tools

MS Office

Job description

Summary

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.

About The Role

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,**********,040,****** 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:

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 ****** and let us know the nature of your request and your contact information. Please include the job requisition number in your message

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Benefits And Rewards

Learn about all the ways we'll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)