Compliance Lead

6 days ago


College Station, Texas, United States FUJIFILM Corporation Full time
Job Summary

We are seeking a highly skilled Senior Compliance Specialist to join our Manufacturing team at FUJIFILM Corporation. As a key member of our compliance team, you will be responsible for ensuring that our manufacturing operations meet the highest standards of quality and regulatory compliance.

Key Responsibilities
  • Compliance Management: Lead and manage all manufacturing-related compliance activities, including CAPAs, change controls, and deviations.
  • Investigation and Resolution: Conduct thorough investigations into manufacturing-related issues and develop effective corrective and preventive actions.
  • Regulatory Compliance: Ensure that our manufacturing operations comply with all relevant regulatory requirements, including cGMP regulations.
  • Quality Assurance: Collaborate with Quality Assurance teams to ensure that all quality-related activities are conducted in accordance with established procedures.
  • Training and Development: Provide training and support to colleagues on compliance-related topics and ensure that all employees understand their roles and responsibilities in maintaining compliance.
Requirements
  • Education: Bachelor's degree in a relevant field, such as life sciences or engineering.
  • Experience: Minimum 5 years of experience in a compliance or quality assurance role in a regulated industry.
  • Skills: Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. Strong analytical and problem-solving skills, with the ability to interpret complex data and develop effective solutions.
Preferred Qualifications
  • Experience with cGMP regulations: Familiarity with cGMP regulations and guidelines, with experience in implementing and maintaining compliance programs.
  • Leadership experience: Experience leading teams and managing projects, with a proven track record of success in a compliance or quality assurance role.


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