Raleigh Site Quality Director - Patient-Safety & Compliance

Indivior PLC; Raleigh (NC); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Bonus program

LTIP grant (Long‑Term Incentive Plan)

401(k) and Profit‑Sharing Plan

Employee Stock Purchase Plan (ESPP)

Medical/Dental/Vision/Life & Disab

Tuition reimbursement

Wellness programs

Adoption assistance

Job summary

Indivior PLC in Raleigh seeks a Director of Site Quality to lead sterility assurance, batch disposition, and patient safety within a high‑risk manufacturing environment, reporting to the VP, Quality Management. You will act as the primary site liaison for FDA inspections and drive cross‑functional quality improvements.

The role requires strategic oversight of QA, QC, microbiology, aseptic processing, validation and site quality systems, with a track record of successful Health Authority

Qualifications

• Bachelor of Science degree in a life science or engineering discipline; postgraduate degree preferred.
• Leadership experience in pharmaceutical/biopharma or biologics, with sterile DP manufacture/testing.
• Proven track record in Health Authority inspections.
• Thorough understanding of regulatory testing, manufacturing, and packaging requirements.
• Experience with US, EU and Asia markets.
• Strong communication and problem-solving skills.

Responsibilities

• Hold site-level accountability for sterility assurance, batch disposition, and patient safety.
• Act as the primary site representative for FDA and global Health Authority inspections, committing the organization to remediation strategies and owning critical compliance outcomes.
• Provide strategic and tactical site level oversight for quality operations across QA, QC, microbiology, aseptic processing, validation, contamination control, training, and site quality systems.
• Identify and resolve compliance issues in alignment with the global Quality function, implementing continuous improvements and driving a culture of quality at the site.
• Secure and work cross-functionally to support routine commercial manufacturing and compliant safe drug products.
• Develop and execute the site quality strategy to ensure continued release of compliant product in a streamlined manner, keeping products available to patients without disruption.
• Attract, develop and lead Quality functions at the site, including QA, QC, microbiology, aseptic processing, validation, contamination control, training and site quality systems.

Skills

Leadership

Quality systems

Regulatory knowledge

cGxP compliance

Inspection readiness

Cross-functional collaboration

Education

Bachelor of Science in life science or engineering

Postgraduate degree preferred

Job description

Indivior PLC in Raleigh seeks a Director of Site Quality to lead sterility assurance, batch disposition, and patient safety within a high‑risk manufacturing environment, reporting to the VP, Quality Management. You will act as the primary site liaison for FDA inspections and drive cross‑functional quality improvements.

The role requires strategic oversight of QA, QC, microbiology, aseptic processing, validation and site quality systems, with a track record of successful Health Authority