Director, Site Quality - Raleigh
Indivior
12 hours ago
On-site
Raleigh, NC
Operations
Position Overview / Responsibilities:
- Strategic and tactical, hands-on Director-level role reporting to VP, Quality Management.
- Ensure Indivior activities and commercial products comply with Marketing Authorizations and cGxP; accountable for sterility assurance, batch disposition, and patient safety.
- Primary site representative for FDA and global Health Authority inspections; commit to remediation strategies; own critical compliance outcomes.
- Lead site quality strategy; manage/escalate quality and compliance issues; provide site decision authority to halt operations and reject product.
- Provide oversight for QA, QC, microbiology, aseptic processing, validation, contamination control, training, and site quality systems (Site Leadership Team).
- Establish and maintain cGMP and QMS effectiveness; manage document management in compliance.
- Ensure non-conformance investigations with root cause analysis and CAPA effectiveness; manage change management, deviations, and lab investigations.
- Approve/reject components/raw materials/intermediates; disposition product for release; provide supplier quality oversight.
- Ensure training (cGxP/process) and conduct Quality Management Reviews using KPIs.
- Participate in technology transfer and manage cGxP critical events/recalls; manage stability studies.
Qualifications / Required & Preferred Skills:
- BS in life science or engineering (postgraduate preferred).
- Direct leadership experience in pharma/biopharma/biologics with sterile DP manufacture/testing.
- Successful history with Health Authority inspections and follow-up.
- Deep knowledge of regulatory requirements for testing, manufacturing, packaging (21 CFR 210/211; cGMP; FDA/OSHA; EU GMP; WHO; PIC/S; 21 CFR 4/820) plus ICH GxP/CT/GLP (ICH E6/E2A/E8; 21 CFR 50; Directive 2004/9/EC; 21 CFR 58).
- Strong understanding of cGxP risk assessment (safety/quality/efficacy) including product quality complaints; pharmaceutical/quality management processes and verifications/validations.
- Experience hosting Competent Authority inspections.
- Strong analytical/problem-solving, planning/organization, interpersonal, and auditing skills.
- Experience managing controlled substances (recommended) and contract/outsourced organizations (plus).
- Proficient in English; other languages advantageous.
- Strategic and tactical, hands-on Director-level role reporting to VP, Quality Management.
- Ensure Indivior activities and commercial products comply with Marketing Authorizations and cGxP; accountable for sterility assurance, batch disposition, and patient safety.
- Primary site representative for FDA and global Health Authority inspections; commit to remediation strategies; own critical compliance outcomes.
- Lead site quality strategy; manage/escalate quality and compliance issues; provide site decision authority to halt operations and reject product.
- Provide oversight for QA, QC, microbiology, aseptic processing, validation, contamination control, training, and site quality systems (Site Leadership Team).
- Establish and maintain cGMP and QMS effectiveness; manage document management in compliance.
- Ensure non-conformance investigations with root cause analysis and CAPA effectiveness; manage change management, deviations, and lab investigations.
- Approve/reject components/raw materials/intermediates; disposition product for release; provide supplier quality oversight.
- Ensure training (cGxP/process) and conduct Quality Management Reviews using KPIs.
- Participate in technology transfer and manage cGxP critical events/recalls; manage stability studies.
Qualifications / Required & Preferred Skills:
- BS in life science or engineering (postgraduate preferred).
- Direct leadership experience in pharma/biopharma/biologics with sterile DP manufacture/testing.
- Successful history with Health Authority inspections and follow-up.
- Deep knowledge of regulatory requirements for testing, manufacturing, packaging (21 CFR 210/211; cGMP; FDA/OSHA; EU GMP; WHO; PIC/S; 21 CFR 4/820) plus ICH GxP/CT/GLP (ICH E6/E2A/E8; 21 CFR 50; Directive 2004/9/EC; 21 CFR 58).
- Strong understanding of cGxP risk assessment (safety/quality/efficacy) including product quality complaints; pharmaceutical/quality management processes and verifications/validations.
- Experience hosting Competent Authority inspections.
- Strong analytical/problem-solving, planning/organization, interpersonal, and auditing skills.
- Experience managing controlled substances (recommended) and contract/outsourced organizations (plus).
- Proficient in English; other languages advantageous.