Director, QARA LATAM, Distribution & Ops
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Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .
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:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
Bogotá Distrito Capital Colombia Mexico City Mexico São Paulo BrazilJob 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 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.
DePuy Synthes is recruiting for a(n) DirectorQARA LATAM Local Market Supportlocatedin SãoPaulo SãoPaulo or Bogota Colombia or Mexico City Mexico
Job Overview
TheDirector QARA LATAM Distribution & Opsprovides strategic leadership for quality assurance and regulatory affairs across Latin America as part of theInternational QARAorganization. This role is accountable for ensuring regulatory compliance effective quality management system execution and sustainable market access across diverse and highly regulated LATAM markets.
This roleplays a critical role in safeguarding patient safety enabling compliant business growth and supportinglongtermportfolio success. The Director partners closely with Commercial Operations Supply Chain Legal and Global QARA leaders to manage quality and regulatory risk and guide regional strategy.
Key Responsibilities
Lead and execute the Quality Assurance and Regulatory Affairs strategy across LATAM in alignment with global QARA objectives and international business priorities.
Ensure ongoing compliance withcountryspecific regulatory requirements applicable regional standards internal policies and DePuy Synthes quality management system expectations.
Provide strategic quality and regulatory guidance to support product registrations renewals variations and full lifecycle management across LATAM markets.
Serve as the senior QARA escalation point for LATAM Local Market Support addressing regulatory quality and compliance risks.
Partner with crossfunctional stakeholders including Commercial Operations Supply Chain Legal and Global QARA to support product launches supply continuity and portfolio optimization.
Monitor interpret and communicate regulatory quality and enforcement trends across LATAM proactively assessing business and patient safety impact.
Oversee and support regulatory inspections quality audits and health authority interactions ensuringtimely consistent and effective responses.
Drive continuous improvement harmonization and simplification of QARA processes across LATAM markets.
Lead coach and develop regional QARA leaders and teams building strong capability succession and a culture of quality compliance and accountability.
Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy continuity and growth.
Define distributor markets and design processes and systems that enable an efficient Distribution Management structure.
Qualifications
Education
Required: Bachelors degree in Regulatory Affairs Life Sciences Engineering ora relateddiscipline.
Preferred: Advanced degree or professional certification in Regulatory Affairs Quality ora relatedfield.
Experience and Skills
Required:
1012 years of progressive experience in Quality Assurance and/or Regulatory Affairs within medical devices or other highly regulated industries.
Strong working knowledge of LATAM regulatory requirements quality system standards and enforcement practices.
Demonstrated experience leading multicountry or regional QARA portfolios.
Proven ability to develop and execute integrated quality and regulatory strategies aligned with businessobjectives.
Experienceoperatingeffectively in global matrixed organizations with senior executive stakeholder engagement.
Strong leadership presence sound judgment and decisionmaking capabilities in complex regulatory environments.
Preferred:
Experience supporting or emerging market QARA operating models.
Experience working in multinational or matrixed organizations.
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 internal employees contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills:
Business Writing Collaborating Compliance Risk Continuous Improvement Developing Others Fact-Based Decision Making Inclusive Leadership Industry Analysis Innovation Leadership Legal Support Operations Management Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Strategic ThinkingRequired Experience:
Director
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
