Senior Quality Manager - GMP & Compliance on Site

ThermoFisher Scientific; Tijuana; On-site; MXN 900,000 - 1,300,000; Full time

Job summary

Thermo Fisher Scientific in Mexico seeks a Senior Quality Manager to lead the site Quality System and support manufacturing operations on site. You will drive compliance, CAPA, audits, and continuous improvement, ensuring products meet regulatory requirements while fostering a culture of quality ownership.

Collaborating with Operations, Engineering, and Supply Chain, you will mentor the Quality team, implement robust processes, and deliver measurable KPI improvements on quality performance.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, Manufacturing, or a related technical discipline.
• Experience in Quality within a manufacturing environment.
• Experience with Quality Management Systems and key Quality processes, including CAPA, complaints, nonconformances, investigations, and audits.
• Experience supporting manufacturing operations and resolving shop-floor Quality issues.
• Experience leading, developing, or providing direction to Quality professionals.
• Strong knowledge of root cause analysis, corrective action, risk assessment, and continuous improvement methodologies.
• Ability to analyze Quality data, establish priorities, and drive measurable improvement against KPIs.
• Strong communication, collaboration, and influencing skills with the ability to work effectively across multiple functions and organizational levels.
• Willingness to maintain a significant on-site presence

Responsibilities

• Lead and maintain site Quality System processes in accordance with applicable regulatory requirements, industry standards, and company policies and procedures.
• Provide oversight and governance for CAPA, complaints, nonconformances, deviations, change control, and other applicable Quality System processes.
• Ensure Quality System records are appropriately investigated, documented, risk-assessed, and completed within established timelines.
• Monitor Quality System health and identify systemic trends, recurring issues, and opportunities for improvement.
• Ensure appropriate root cause analysis and corrective actions are implemented and verified for effectiveness.
• Support and/or lead Quality Management Review activities and provide meaningful insights into site Quality performance.
• Lead site readiness for internal, customer, regulatory, and certification audits.
• Coordinate audit preparation, execution, responses, and closure of resulting observations or corrective actions.
• Maintain a state of continuous inspection and audit readiness.
• Partner with site leadership and functional teams to identify compliance risks and ensure timely remediation.
• Promote sustainable compliance practices that are integrated into day-to-day operations.
• Maintain a visible and active Quality presence on the manufacturing floor
• Partner closely with Manufacturing leadership and operators to resolve Quality issues quickly while maintaining appropriate Quality and compliance standards.
• Ensure timely Quality support for production issues, nonconforming material, investigations, disposition activities, and manufacturing-related Quality decisions.
• Drive proactive identification of Quality risks before they result in product failures, customer complaints, or production disruptions.
• Support manufacturing teams in developing robust processes, controls, and problem-solving capabilities.
• Promote Quality at the source and strengthen ownership of Quality across manufacturing operations.
• Establish, monitor, and drive performance against site Quality KPIs and operational Quality objectives.
• Use data and trend analysis to identify emerging risks, recurring failure modes, and improvement opportunities.
• Develop and execute recovery plans when Quality metrics are not meeting expectations.
• Partner with Operations and other functions to improve key performance indicators such as first-pass yield, scrap/rework, nonconformance rates, CAPA effectiveness and closure, complaint performance, audit findings, and cost of poor quality
• Communicate Quality performance, risks, priorities, and actions effectively to site leadership.
• Lead and support continuous improvement initiatives that improve product quality, process capability, compliance, efficiency, and customer experience.
• Drive structured problem solving and effective root cause analysis using appropriate methodologies and Quality tools.
• Identify opportunities to simplify and strengthen Quality processes while maintaining compliance and effectiveness.
• Use Quality data and manufacturing insights to prioritize improvement efforts based on risk and business impact.
• Partner with Manufacturing, Engineering, and other functions to reduce recurring defects, variation, waste, and Quality-related disruptions.
• Promote a culture that moves beyond correcting individual issues toward preventing recurrence and eliminating systemic causes.
• Lead, coach, and develop the site Quality team to ensure strong technical capability, accountability, and business partnership.
• Establish clear expectations, priorities, and performance objectives for the team.
• Ensure appropriate Quality coverage and support for manufacturing operations.
• Develop team members' capabilities in Quality Systems, manufacturing Quality, problem solving, risk management, and continuous improvement.
• Create a culture where Quality team members are comfortable working both within formal Quality Systems and directly alongside manufacturing teams.
• Foster collaboration, transparency, urgency, and fact‑based decision‑making across the organization.

Skills

Quality leadership

Root cause analysis

Regulatory compliance knowledge

Process improvement

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Science, Quality, Manufacturing, or related field

Job description

Thermo Fisher Scientific in Mexico seeks a Senior Quality Manager to lead the site Quality System and support manufacturing operations on site. You will drive compliance, CAPA, audits, and continuous improvement, ensuring products meet regulatory requirements while fostering a culture of quality ownership.

Collaborating with Operations, Engineering, and Supply Chain, you will mentor the Quality team, implement robust processes, and deliver measurable KPI improvements on quality performance.