R&D Senior Quality

Há 1 mês

São José dos Campos, Brasil Kenvue Tempo inteiro

This position reports to Franchise Quality Manager and is based at São José dos Campos.

Who we are

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson’s and BAND-AID Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you Join us in shaping our future–and yours.

Role reports to: Quality & Compliance Manager

Travel %: 10%

What you will do

The R&D Senior Quality & Compliance Analyst is responsible as a Q&C representative in the R&D organization, managing all quality activities related to GxP laboratories and R&D product development activities. The role focuses on solving technical problems related to the interpretation and implementation of regulations, compliance, and standards within its scope. This professional must have deep technical knowledge to attend internal/external and regulatory audits, along with knowledge of quality tools and laboratory management.

Key Responsibilities

  • Ensure attendance to the GxP requirements for Pilot Plant and R&D Labs.
  • Revise and approve protocols and reports related to test methods development and validations, equipment management, and other required activities.
  • Develop and revise standard operating procedures and specific GMP/GLP documentation within R&D Compliance processes and R&D processes.
  • Proactively investigate and develop improvements to existing processes or develop new processes.
  • Conduct batch record reviews and issue product certificate of conformance.
  • Lead compliance projects to promote continuous improvement within R&D specific processes for pilot plant and/or R&D laboratories.
  • Interact with and provide guidance to R&D professionals on GxP regulatory requirements.
  • Interpret regulations to provide risk analysis guidance and make decisions about R&D GxP activities accurately.
  • Lead and/or support the internal and external Q&C audit program, regulatory inspections, and Inspection Readiness Program.
  • Lead investigations, CAPA, and change controls.

What we are looking for

Required Qualifications

  • Bachelor’s Degree in Pharmacy, Chemistry, Engineering, or related science is required. Pharmacy is preferred.
  • Proven experience of at least 4 - 6 years in a regulated industry. Pharmaceutical Industry is preferred.
  • Experience in quality control and/or analytical development laboratory.
  • Working knowledge of CAPA, Change Control, and General Quality Systems process.
  • Knowledge of regulatory environment related to laboratory and method development and validation.
  • Advanced knowledge of Microsoft Office (Excel, PowerPoint, Word).
  • Advanced English.

Desired Qualifications

  • Knowledge of regulatory requirements for North America such as FDA.
  • Excellent problem-solving and analytical skills.
  • Excellent communication and coaching skills.
  • Experience in conducting audits for compliance.
  • Advanced technical training and experience using Statistics, Lean, and Six Sigma Methodologies.

What’s in it for you

  • Competitive Total Rewards Package*
  • Paid Company Holidays, Paid Vacation, Volunteer Time & More
  • Learning & Development Opportunities
  • Employee Resource Groups
  • This list could vary based on location/region.

Note: Total Rewards at Kenvue include salary, bonus (if applicable), and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

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