CQ Sr Analyst, Colombia

Johnson Johnson; Bogotá ciudad; Presencial; COP 60.000.000 - 90.000.000; Jornada completa

Descripción de la vacante

Johnson & Johnson seeks a CQ Sr Analyst in Colombia, based in Bogota, to govern the Commercial Quality QMS across the region. You will partner with Commercial, Distribution, Supply Chain, Regulatory Affairs, and Global Quality to ensure compliant quality processes and continuous improvement.

The role emphasizes governance, training, and audits. Ideal candidates have 5+ years in quality-related functions within regulated industries, fluent Spanish and Portuguese, and strong analytical and

Formación

• Bachelor's degree in a related field (Engineering, Life Sciences, Pharmacy, Quality, Regulatory Affairs, Supply Chain, Business Administration)
• Advanced degree preferred
• 5+ years in Quality Assurance, Quality Systems, or related fields in a regulated environment

Responsabilidades

• Lead governance, deployment, and improvement of the Commercial Quality QMS regionally
• Provide quality oversight for handling, storage, and distribution activities
• Ensure regulatory compliance and remediation of identified gaps
• Drive data-driven quality improvements via metrics and CAPA
• Collaborate with Commercial, Supply Chain, Regulatory Affairs, and Global Quality teams
• Provide training and quality guidance to regional teams
• Support audits and regulatory inspections and drive audit readiness

Conocimientos

Analytical thinking

Problem solving

Communication skills

Stakeholder management

Influencing skills

Spanish fluency

Portuguese fluency

Educación

Bachelor's Degree

Advanced degree

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: Quality

Job Sub Function: Customer/Commercial Quality

Job Category: Professional

All Job Posting Locations: Bogotá, Distrito Capital, Colombia

Job Description:

DePuy Synthes is recruiting for a CQ Sr Analyst, Colombia , located in Bogota, Colombia .

Job Overview

The Commercial Quality Analyst is responsible for the governance, deployment, maintenance, and continuous improvement of the Commercial Quality QMS across the region. This role serves as a Subject Matter Expert (SME) for quality system processes and ensures compliance with applicable regulatory requirements, company standards, and commercial quality policies.

The position partners closely with Commercial, Distribution, Supply Chain, Regulatory Affairs, Operations, and Global Quality organizations to ensure effective implementation and sustainability of quality system processes throughout the commercial network. The role also supports the deployment of regional quality initiatives, drives process harmonization across countries, and promotes a culture of quality and compliance.

Key Responsibilities

• Lead the implementation and sustainment of QMS requirements, procedures, systems, and initiatives throughout the region, ensuring alignment with business needs and applicable regulatory requirements.
• Provide quality oversight for handling, storage, distribution, and other commercial operations, ensuring appropriate controls are established and maintained to protect product quality and patient safety.
• Drive compliance and effectiveness of quality system processes including document management, training, investigations, CAPA, change management, quality risk management, and management review activities.
• Monitor and analyze quality metrics, trends, and process performance indicators to identify risks, drive continuous improvement initiatives, and support management decision-making.
• Partner with Commercial, Supply Chain, Distribution, Regulatory Affairs, and Global Quality stakeholders to ensure consistent execution of quality requirements and resolution of quality and compliance issues.
• Provide technical guidance, training, and quality expertise to regional teams, supporting the development of quality capabilities and a culture of compliance and continuous improvement.
• Support internal and external audits, regulatory inspections, and assessment activities, ensuring audit readiness and effective remediation of identified gaps.
• Demonstrate DePuy Synthes's Credo values in all activities through a commitment to quality, compliance, integrity, patient safety, customer focus, and accountability.

Qualifications

Education

• Bachelor's Degree required in Engineering, Life Sciences, Pharmacy, Quality, Regulatory Affairs, Supply Chain, Business Administration, or a related field.

Advanced degree

• Advanced degree is preferred.

Experience and Skills

Required

• Minimum 5 years of experience in Quality Assurance, Quality Systems, Supply Chain Quality, Regulatory Affairs, or other quality-related functions within a regulated industry.
• Experience implementing, maintaining , and improving Quality Management Systems.
• Experience supporting commercial operations, including handling, storage, and distribution activities.
• Experience working in cross-functional and regional environments.
• Strong analytical, problem-solving, and risk-based decision-making skills.
• Strong communication , stakeholder management, and influencing skills.
• Fluent in Spanish and Portuguese.

Preferred

• Experience within the Medical Device, Healthcare, Pharmaceutical, or related regulated industry.
• Experience leading regional deployment of quality processes, systems, or initiatives.
• Experience supporting audits, inspections, and compliance programs.
• English proficiency is desirable.

Other

• Travel: Limited domestic or international travel may be required ( generally 10%).
• Quality-related certifications, auditor qualifications, or equivalent professional training are preferred. (e.g., ISO Internal/Lead Auditor, ASQ Certified Quality Engineer, Six Sigma certifications).

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedic