Onsite Senior Quality Operations Lead

Posted 51 minutes ago

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About the role

  • Senior Quality Operations Lead at Johnson & Johnson ensuring quality assurance in production and leading quality operations teams in Georgia.

Responsibilities

  • Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards.
  • Serves as the Quality Operations Site Lead and overseeing day-to-day quality operations.
  • Verifies that the Quality System is in place and maintained at the required compliance level.
  • Drives Quality System efficient execution and reduced risk of non-conforming product.
  • Establishes and maintains quality assurance programs, procedures, and controls.
  • Ensures that performance and quality of products conform to established company and regulatory standards.
  • Analyzes data sources significant quality trends and recommends actions as needed.
  • Reviews and approves non-conformances, CAPA, Audit Observations, Change Controls, Validations and Completion Reports, and other quality system documents or records as required.
  • Manages the qualification and validation for all products and processes and quality control support activities.
  • Supports investigation, evaluation, and implementation of actions to eliminate root causes of non-conformances.

Requirements

  • A minimum of a Bachelor or Equivalent University degree is required.
  • Generally, Requires 8-10 Years Work Experience
  • Bachelor’s degree in a Technical or Science field
  • Eight (8) years active management experience including direct supervision and matrix management
  • Thirteen (13) years related experience and/or training or an equivalent combination of education and experience
  • Experience in front-room role with FDA (or similar) inspection and Notified Body inspection
  • Successful management of a multinational department and/or significant QA project
  • Statistical and analytical problem solving.
  • Certified in PE tools (preferred)
  • Preferred knowledge of lean manufacturing and manufacturing processes
  • Excellent oral communication and technical writing skills
  • Good decision-making skills.

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Professional development

Job title

Senior Quality Operations Lead

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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