Senior CQ Analyst - Mexico

Biopharma Careers; Bogotá; Presencial; MXN 550.000 - 750.000; Jornada completa

Descripción de la vacante

Johnson & Johnson’s Commercial Quality Analyst – Mexico supports quality activities for the Mexican market, ensuring compliance with regulatory and quality standards. The role partners with Commercial, Regulatory Affairs, and Supply Chain to safeguard patient safety and business continuity.

The position requires a Bachelor’s in Quality/Engineering/Life Sciences or Regulatory Affairs, plus 2–4 years in quality/regulatory roles; English proficiency preferred.

Formación

• Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or related (required).
• Advanced degree in a scientific, quality, or regulatory field (preferred).
• Typically 2–4 years of experience in Quality, Regulatory, or Compliance roles within a regulated industry.

Responsabilidades

• Support regulatory/commercial quality activities to ensure compliance with requirements and internal policies.
• Assist with post-market surveillance, including complaint handling, adverse event reporting, and field action support.
• Collaborate with Commercial, Regulatory Affairs, and Supply Chain teams to support compliant product distribution and lifecycle activities.
• Support implementation and adherence to global and local quality procedures, work instructions, and controls.
• Participate in internal and external audits and health authority inspections as required.
• Monitor quality issues, trends, and metrics and support corrective actions.

Conocimientos

Audit Management

Data Analysis

Quality Control

Regulatory Environment

Problem Solving

Detail-Oriented

Communication

Educación

Bachelor's in Quality/Engineering/Life Sciences/Regulatory

Advanced degree (preferred)

Descripción del empleo

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

• Bogotá, Distrito Capital, Colombia
• Mexico City, Mexico

Job Description:

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Job Overview

The Commercial Quality Analyst – Mexico supports the execution of quality activities for commercial operations within the Mexican market. This role helps ensure that sales, distribution, and post‑market activities comply with applicable regulatory requirements, quality system standards, and internal procedures. The position contributes directly to patient safety, regulatory compliance, and business continuity while partnering with Commercial, Regulatory Affairs, and Supply Chain teams.

Key Responsibilities

• Support commercial quality activities to ensure compliance with regulatory requirements, quality system standards, and internal policies.
• Assist with post‑market surveillance activities, including complaint handling, adverse event reporting, and field action support.
• Collaborate with Commercial, Regulatory Affairs, and Supply Chain teams to support compliant product distribution and lifecycle activities.
• Support implementation and adherence to global and local quality procedures, work instructions, and controls.
• Participate in internal audits, external audits, and health authority inspections as required .
• Monitor quality issues, trends, and metrics within the local market and support corrective and preventive actions.
• Maintain accurate quality documentation, records, and reports related to commercial quality activities.
• Contribute to continuous improvement initiatives to strengthen quality compliance and operational effectiveness.

Qualifications

Education:

• Bachelor’s degree in Quality , Engineering, Life Sciences, Regulatory Affairs, or a related discipline (required).
• Advanced degree in a scientific, quality, or regulatory field (preferred).

Experience and Skills:

Required:

• Typically 2-4 years of experience in Quality, Regulatory, or Compliance roles within a regulated industry.
• Foundational understanding of quality system requirements and regulatory expectations for commercial operations.
• Experience supporting post‑market surveillance activities, audits, or inspections.
• Ability to interpret quality procedures and regulatory requirements and apply them to daily activities.
• Strong attention to detail, documentation, and organizational skills.
• Effective communication and cross‑functional collaboration skills.

Preferred:

• Experience in medical devices, healthcare, or other highly regulated industries.
• Familiarity with Mexican regulatory and quality requirements (e.g., COFEPRIS).
• Experience working in a multinational or matrixed organization.
• Exposure to health authority interactions or regulatory inspections.
• Quality or Regulatory certifications.

Other:

• Language: Spanish required ; English proficiency preferred.
• Travel: Limited; occasional domestic travel within Mexico.
• Certifications: Quality or Regulatory certifications preferred but not required .

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

• Audit Management
• Business Behavior
• Coaching
• Compliance Management
• Continuous Improvement
• Data Analysis
• Detail-Oriented
• Goal Attainment
• Internal Controls
• Issue Escalation
• Problem Solving
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Regulatory Environment