Senior Regulatory and Quality Specialist
PathAI
Senior Regulatory and Compliance Specialist
Ardena Careers
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $100,000 - $120,000 per year
Job Level
Senior
About the role
- Facilitate and host customer audits at the Somerset site to ensure compliance with cGMP’s, as well as international regulatory compliance and site standard operating procedures
- Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health authority regulations
- Lead the activities for preparing an oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities
- Participate in all aspects of inspections from initiation, preparation, execution through closure
- Assist in preparing for PAI audits for new product approvals at site, compiling documents and reviewing to ensure audit readiness
- Review and approve Quality Management System Records as needed acting as a QA Representative
- Collaborate with Supplier Quality, Regulatory Compliance, DEA, and QMS functional areas
Requirements
- A bachelor’s degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related functions
- Associate degree or High School Diploma with 10+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function
- Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field is required
- Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities is required
- Understanding of various audit types (e.g. Customer, Supplier, Agency etc.) and techniques (e.g. Onsite, Questionnaire etc.) is preferred
- Demonstrated experience with customer and internal audits is preferred
- Demonstrated experience with Health Authority Inspections (front or back room) is highly preferred
- Soft skills that align with our CARE values- Communicative, Accountable, Reliable, and Excellent
