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 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 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. 

 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. 

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