Manager, CQ Lead, BR & Southern Cluster
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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:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
São Paulo BrazilJob Description:
DePuy Synthes is recruiting for a Manager CQ Lead BR & Southern Cluster located in São Paulo Brazil
Job Overview
This role provides regionalCommercialQuality (CQ) leadership for Brazil and the Southern Cluster within QARA Internationalorganization ensuring robust quality systems regulatory compliance and continuous improvement across the product lifecycle. The Manager CQ Lead partners closely with commercial medical supply chain and regulatory teams to proactively manage risk support audits and inspections and drive a culture of quality that protects patients and enables business growth. This is an opportunity to lead at the intersection of compliance strategy and operational excellence in a dynamic MedTech environment.
Key Responsibilities
Lead and overseeCommercialQuality activities for Brazil and the Southern Cluster ensuring compliance with applicable regulations standards and internal quality systems.
Serve as the primary CQ partner to regional stakeholders providing guidance on quality risk management issue escalation and remediation strategies.
Support andfacilitateregulatory inspections audits and internal assessments including preparation execution andfollowupactions.
Drive continuous improvement initiatives to strengthencommercialquality processes documentation and compliance effectiveness across the region.
Review approve andmaintainquality documentation including procedures work instructions and records aligned with global QARA standards.
Lead investigation and resolution of quality events deviations and CAPAs ensuringtimelyand sustainable outcomes.
Provide coaching and leadership to regional CQ resources fostering capabilitybuildingand a strong quality culture.
Collaborate with global QARA partners to support new product introductions lifecycle management andpostmarketactivities from acommercialquality perspective.
Qualifications
Education
Bachelors degreein Life Sciences Engineering Pharmacy Nursing ora relateddiscipline.
Advanceddegree(Masters MBA or equivalent) preferred.
Experience and Skills
8-10years of progressive experience in QualityCommerciaQuality Regulatory or related functions within medical devices or regulated healthcare industries.
Demonstrated experience working with quality management systems and regulatory requirements in a regional or international context.
Proven ability to lead investigations audits and CAPA activities with sound judgment and attention to detail.
Strong stakeholder management skills with the ability to influence across functions and levels.
Preferred
Experience supporting Brazilian and Southern Cluster regulatory environments within MedTech or Life Sciences.
Priorpeopleleadership or matrix leadership experience.
Familiarity withcommercialqualitypostmarketsurveillance andriskbasedquality approaches.
Experience partnering with global or regional QARA organizations.
Excellent written and verbal communication skills including documentation andinspectionreadiness.
Other
Languages: Portuguese and Englishproficiency; Spanish preferred.
Travel: Limited regional travel as business needs require.
Certifications: Quality or regulatory certifications (e.g. ISO Six Sigma RAC) preferred.
For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit.
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.
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:
Coaching Compliance Management Consulting Continuous Improvement Fact-Based Decision Making ISO 9001 Performance Measurement Process Improvements Quality Control (QC) Quality Management Systems (QMS) Quality Standards Regulatory Environment Stakeholder Engagement Standard Operating Procedure (SOP) Technical CredibilityRequired Experience:
Manager
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
