Director, Site Quality - Raleigh
Indivior
September 08, 2026
Full-time
On-site
Raleigh, NC
Operations
Role: Director of Site Quality at Indivior's Raleigh manufacturing site, responsible for overseeing quality operations in a sterile pharmaceutical environment focused on opioid use disorder treatments. Responsibilities include leading QA, QC, microbiology, aseptic processing, validation, contamination control, and site quality systems; ensuring compliance with cGMP, FDA, and global regulatory standards; managing inspections, deviations, investigations, and CAPAs; and developing site quality strategies to ensure compliant product release without disruption.
Requirements: Bachelor's in life sciences or engineering; extensive leadership experience within biopharma or pharmaceutical manufacturing, particularly in sterile drug products; proven success in regulatory inspections and compliance with cGxP, CFR 21, FDA, EMA, and other international standards; strong knowledge of validation, manufacturing, and quality processes; excellent communication, analytical, and problem-solving skills.
Preferred: Postgraduate degree; experience managing external suppliers and host inspections; proficiency in controlled substances management; experience with regulatory bodies and diverse global markets.
High-Value: Focus on sterile drug manufacturing for opioid use disorder, cGxP compliance, global regulatory interactions, and quality leadership in a high-risk, regulated environment. Position entails significant cross-functional collaboration, regulatory interaction, and strategic quality oversight.
Requirements: Bachelor's in life sciences or engineering; extensive leadership experience within biopharma or pharmaceutical manufacturing, particularly in sterile drug products; proven success in regulatory inspections and compliance with cGxP, CFR 21, FDA, EMA, and other international standards; strong knowledge of validation, manufacturing, and quality processes; excellent communication, analytical, and problem-solving skills.
Preferred: Postgraduate degree; experience managing external suppliers and host inspections; proficiency in controlled substances management; experience with regulatory bodies and diverse global markets.
High-Value: Focus on sterile drug manufacturing for opioid use disorder, cGxP compliance, global regulatory interactions, and quality leadership in a high-risk, regulated environment. Position entails significant cross-functional collaboration, regulatory interaction, and strategic quality oversight.