Director, Site Quality - Raleigh
Indivior
August 20, 2026
On-site
Raleigh, NC
Operations
Responsibilities:
- Lead site quality organization and staff to ensure Indivior activities and products comply with Marketing Authorizations and cGxP/cGMP.
- Provide strategic/tactical oversight for QA, QC, microbiology, aseptic processing, validation, contamination control, training, and site quality systems.
- Identify and resolve compliance issues; drive continuous improvement and a “culture of quality.”
- Manage escalations and quality/compliance issues to VP Quality Management and site leadership; independently halt operations/reject product/escalate risks.
- Ensure sterility assurance, batch disposition, patient safety, investigations (CAPA with effectiveness monitoring), nonconformance/root cause.
- Own regulatory inspection readiness; serve as primary contact for FDA and global Health Authority inspections.
- Establish document management, manufacturing control procedures/specifications, supplier oversight, and QMS effectiveness reporting (KPIs/QMRs).
- Manage cGxP critical events, recalls/mock recalls, stability studies (as applicable), and technology transfer activities.
Qualifications/Skills:
- BS in life science or engineering (MS/advanced preferred).
- Proven leadership experience in sterile DP manufacture/testing (pharma/biopharma/biologics).
- Demonstrated success in Health Authority inspections and follow-up.
- Strong knowledge of cGxP/cGMP and regulatory requirements (e.g., 21 CFR 210/211, EU GMP, WHO, PIC/S; clinical/GLP regulations as applicable).
- Experience with risk assessment of product safety/quality/efficacy and product quality complaints.
- Strong analytical/problem-solving, planning/organization, influencing, auditing skills (advantage).
- Experience managing contract/outsourced organizations and controlled substances (preferred/plus where stated).
- Proficient in English.
Benefits (from posting): Starting salary $200,000–$230,000; bonus; long-term incentive grant; PTO; 401(k) with match; stock purchase discount; medical/dental/vision/life/disability; HSA/FSA options; adoption assistance; tuition reimbursement; concierge services; wellness and voluntary benefits.
- Lead site quality organization and staff to ensure Indivior activities and products comply with Marketing Authorizations and cGxP/cGMP.
- Provide strategic/tactical oversight for QA, QC, microbiology, aseptic processing, validation, contamination control, training, and site quality systems.
- Identify and resolve compliance issues; drive continuous improvement and a “culture of quality.”
- Manage escalations and quality/compliance issues to VP Quality Management and site leadership; independently halt operations/reject product/escalate risks.
- Ensure sterility assurance, batch disposition, patient safety, investigations (CAPA with effectiveness monitoring), nonconformance/root cause.
- Own regulatory inspection readiness; serve as primary contact for FDA and global Health Authority inspections.
- Establish document management, manufacturing control procedures/specifications, supplier oversight, and QMS effectiveness reporting (KPIs/QMRs).
- Manage cGxP critical events, recalls/mock recalls, stability studies (as applicable), and technology transfer activities.
Qualifications/Skills:
- BS in life science or engineering (MS/advanced preferred).
- Proven leadership experience in sterile DP manufacture/testing (pharma/biopharma/biologics).
- Demonstrated success in Health Authority inspections and follow-up.
- Strong knowledge of cGxP/cGMP and regulatory requirements (e.g., 21 CFR 210/211, EU GMP, WHO, PIC/S; clinical/GLP regulations as applicable).
- Experience with risk assessment of product safety/quality/efficacy and product quality complaints.
- Strong analytical/problem-solving, planning/organization, influencing, auditing skills (advantage).
- Experience managing contract/outsourced organizations and controlled substances (preferred/plus where stated).
- Proficient in English.
Benefits (from posting): Starting salary $200,000–$230,000; bonus; long-term incentive grant; PTO; 401(k) with match; stock purchase discount; medical/dental/vision/life/disability; HSA/FSA options; adoption assistance; tuition reimbursement; concierge services; wellness and voluntary benefits.