Job Information
J&J Family of Companies Commercial Quality Sr. Analyst - Fixed Term (1 year) in São José dos Campos, Brazil
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 (https://www.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:
Professional
All Job Posting Locations:
São José dos Campos, São Paulo, Brazil
Job Description:
Job Summary
The role is responsible for ensuring compliance with temperature control, qualification, and validation requirements across commercial quality and warehouse operations. The position acts as a Subject Matter Expert (SME) in temperature control and as a focal point for equipment qualification, computerized systems validation, and regulatory applicability assessments.
Key Responsibilities
Act as Subject Matter Expert (SME) for Temperature Control, ensuring compliance with RDC 430, including thermal qualifications of equipment, areas, and transportation providers.
Lead and execute supplier qualification activities, including technical evaluation, audits, follow‑up actions, and documentation.
Serve as Focal Point for Computerized Systems Validation (CSV), ensuring systems meet regulatory and corporate requirements.
Perform regulatory applicability analyses for Warehouse (WH) operations, including Assessment of Regulatory Requirements (ARR) and definition of mitigation actions.
Act as Focal Point for equipment qualification and thermal studies, coordinating qualification strategies, execution, and lifecycle management.
Support inspections and audits by regulatory authorities, customers, and internal stakeholders related to temperature control, validation, and qualification.
Qualifications & Experience
Bachelor’s degree in Pharmacy, Engineering, Life Sciences, or related field.
Solid experience in Quality, Validation, or Temperature Control within pharmaceutical, biotech, or healthcare environments.
Strong knowledge of RDC 430, good distribution practices, and temperature‑controlled supply chains.
Experience with equipment qualification, thermal mapping, CSV, and supplier qualification.
Ability to act independently as an SME and cross‑functional focal point.
Strong analytical, communication, and stakeholder‑management skills.
Languages
English: Advanced / Fluent
Portuguese: Fluent
Required Skills:
Preferred Skills:
Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment