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Regulatory Compliance Expert

2 months ago

Trenton, New Jersey, United States ALLTECH CONSULTING SVC INC Full time
{"title": "Senior Compliance and Regulatory Specialist", "description": "Job Summary

We are seeking a highly skilled Senior Compliance and Regulatory Specialist to join our team at ALLTECH CONSULTING SVC INC. This role will be responsible for ensuring compliance with global regulations and standards in the pharmaceutical industry.

Key Responsibilities
  • Manage the supplier quality program and ensure compliance with regulatory requirements.
  • Facilitate and host customer audits to ensure compliance with cGMPs and corporate standard operating procedures.
  • Participate in corporate internal audits to ensure compliance with FDA and international health authority regulations.
  • Lead the activities for preparing the manufacturing site for inspections by US FDA and foreign regulatory authorities.
  • Lead the internal audit program at the site.
  • Assist in preparing written responses to address audit findings and ensure compliance.
  • Inform QA management of any non-compliance issues.
  • Initiate deviations when site procedures are not followed.
  • Participate in global supplier and regulatory meetings.
  • Review and approve TrackWise Records as needed.
  • Review and revise departmental SOPs as required.
Requirements
  • Bachelor's degree with 5+ years of experience in Quality/Regulatory Compliance, Quality Assurance, or associated pharmaceutical manufacturing related function.
  • Associate degree or High School Diploma with 10+ years of experience in Quality/Regulatory Compliance, Quality Assurance, or associated pharmaceutical manufacturing related function.
  • Knowledge of US FDA regulatory requirements and cGMP regulations.
  • Deep understanding of various audit types and techniques.
  • TrackWise experience is preferred.
  • ASQ CQA or relevant Certification is highly preferred.
", "lang_code": "en-US"}