Commercial Quality Southern Cluster Manager - Surgery

Buenos Aires J&J; Family of Companies

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

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality
Job Sub Function: Customer/Commercial Quality
Job Category: People Leader
All Job Posting Locations: Buenos Aires, Argentina

Job Description:

About the Role: Lead Commercial Quality operations for Johnson & Johnson's Surgery business across the Southern Cluster, bringing together Market Quality, Quality Management Systems, and Handling, Storage and Distribution (HSD). You will connect country teams and cross-functional partners to strengthen compliance, harmonize processes and resolve quality challenges. Reporting to the Surgery Commercial Quality Senior Manager, will lead the assigned team, turn regional priorities into coordinated action and provide an integrated view of quality performance, risks and improvement opportunities.

Key Responsibilities:

- Lead integrated Commercial Quality execution across countries, aligning priorities, responsibilities and action plans while respecting local regulatory requirements.
- Consolidate quality indicators, country risks and commitments into actionable insights for management review; resolve operational issues and escalate significant matters with clear recommendations.
- Lead and develop assigned direct reports, coordinate the country quality network and partner with Commercial, Deliver Operations, Regulatory Affairs, Medical Safety and other stakeholders to address cross-functional challenges.
- Coordinate product complaint and technovigilance activities, including timely intake, escalation, sample returns, investigation support and follow‑up, working with accountable functions to meet reporting timelines.
- Coordinate local execution of field actions and recalls with designated process owners, including traceability, customer communication and product reconciliation.
- Use complaint trends and customer quality concerns to guide risk reviews and improvement priorities, and coordinate quality support for distributors and commercial partners.
- Oversee quality across assigned handling, storage, transportation and distribution activities, partnering with Deliver and country teams on warehouse and logistics‑provider qualification, quality agreements and periodic reviews.

Required Qualifications:

- Bachelor's or master's degree in Business, Biosciences, Engineering, Chemistry, Pharmacy, a health‑related discipline or an equivalent field.
- Relevant quality leadership experience, typically gained over 6‑8 years, including at least three years in the medical device, pharmaceutical or healthcare industry.
- Knowledge of Commercial Quality and supply chain processes, including product complaints, technovigilance,



field actions and HSD quality oversight.
- Practical experience with audits, inspection readiness, CAPA, change control and quality risk management.
- Demonstrated ability to lead or coach teams and deliver quality and process improvements.
- Strong stakeholder management, negotiation and influencing skills.
- Ability to translate complex operational matters into clear recommendations, risk‑based decisions and timely escalations.
- Professional proficiency in English and Spanish.
- Proficiency with digital tools for data analysis, reporting and collaboration.

Preferred Qualifications:

- Experience coordinating multi‑country operations and working across matrix organizations.
- Project management experience.
- Experience implementing or maintaining ISO‑based or equivalent quality management systems.

Required Skills: Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Developing Others, Fact‑Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards, Standard Operating Procedure (SOP), Team Management

Professional Qualifications & Experience (Commercial Quality Analyst for Argentina MedTech)

Purpose: At Johnson & Johnson MedTech, we are working to transform the future of healthcare by bringing innovative medical technologies to patients and healthcare professionals around the world. Joining our Commercial Quality team means helping ensure that our products, processes, and distribution channels meet high standards of quality, compliance, and patient safety.

You will be responsible for:

- Maintain and support the effectiveness of the Quality Management System (QMS) in compliance with applicable company standards, procedures, and local regulatory requirements, ensuring appropriate quality controls and product traceability throughout the supply chain.
- Lead and support the timely and compliant investigation of deviations, nonconformances, and compliance gaps, including identification, documentation, root and/or assignable cause analysis, and follow‑up through closure. Define and monitor appropriate corrective and preventive actions in collaboration with relevant cross‑functional partners, in accordance with applicable requirements and company procedures.
- Perform product release activities for commercialization in Argentina and provide support to the corresponding release process for Uruguay, ensuring compliance with applicable quality and regulatory requirements.
- Ensure compliance with applicable quality requirements for marketing companies, external manufacturers, packaging, and labeling activities, including the local implementation of applicable Repack & Relabel standards.
- Manage document control activities and Quality Management System documentation in accordance with company requirements, ensuring quality procedures remain current and aligned with corporate standards and applicable local regulations.
- Provide Quality training to warehouse operations personnel on applicable procedures, standards,



and requirements, ensuring appropriate understanding and consistent implementation of established processes.
- Monitor and report Quality Management System performance, including monthly quality metrics and applicable Third‑Party Logistics (3PL) performance indicators.
- Support Product Complaint Management activities, including the appropriate handling, documentation, and coordination of complaint samples.
- Coordinate Stop Shipment notifications and related quality activities in collaboration with Commercial, Regulatory Affairs, Deliver, and other relevant functions.
- Support and participate in the Internal Audit Program, external regulatory inspections, and Corporate Audits, including preparation, execution support, follow‑up, and management of resulting actions, as applicable.
- Partner with Deliver Operations and 3PL partners to drive continuous improvement across warehouse and distribution processes, ensuring alignment with applicable Quality System requirements, company standards, and local regulations.
- Ensure compliance with quality requirements associated with Master Data processes, including appropriate management and oversight of relevant quality activities.
- Conduct GEMBA Walks at the 3PL warehouse to monitor adherence to applicable Quality procedures and identify opportunities for continuous improvement.

Mandatory Qualifications

- Bachelor's degree in Pharmacy, Biochemistry, Engineering, Life Sciences, or a related field.
- Previous experience in Quality, Quality Assurance, Quality Systems, Operations Quality, or a related function within a regulated industry.
- Intermediate English proficiency.
- Intermediate to advanced proficiency in Microsoft Office applications.

Preferred Qualifications

- Previous experience in the Medical Device, Pharmaceutical, or Healthcare industry.
- Experience working with warehouse, distribution, logistics, or Third‑Party Logistics (3PL) operations.
- Knowledge of product release, complaint management, audits, inspections, and distribution quality processes.
- Familiarity with GxP requirements and risk‑based Quality Management principles.
- Experience collaborating with Regulatory Affairs, Supply Chain/Deliver, Commercial, or other cross‑functional teams.
- Knowledge of applicable Argentinian medical device regulatory requirements.
- Experience with SAP or similar ERP systems.

Key Competencies

- Strong knowledge of Quality Management Systems and quality principles in a regulated environment.
- Strong analytical, problem‑solving, and root cause investigation skills, with a risk‑based mindset.
- High level of attention to detail, organization, and accountability.
- Ability to effectively manage multiple priorities and meet established timelines.
- Strong communication and training skills, with the ability to translate Quality requirements into clear guidance for operational teams.
- Strong collaboration and stakeholder management skills, with the ability to work effectively across cross‑functional teams and external partners.
- Continuous improvement mindset, with a proactive approach to identifying opportunities to strengthen Quality and operational processes.
- Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, experience generating effective prompts to boost efficiency and productivity, and awareness of AI's impact on the workforce.

Location: Buenos Aires, Argentina

J&J; MedTech

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