GLP Vendor QA & Compliance Lead

CSL Seqirus Inc.; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

CSL Seqirus is seeking a Vendor/Supplier QA Auditor to oversee external partners supporting R&D and regulated activities, ensuring GLP/GCP/GMP/GVP compliance and data integrity.

You will lead the end-to-end vendor lifecycle, including due diligence, qualification, quality agreements, risk-based monitoring, CAPA handling, and continuous improvement, collaborating with Clinical, Nonclinical, CMC, Safety, Procurement, Legal and IT to enable reliable third-party delivery.

Qualifications

• 3+ years of GxP quality experience with direct vendor/CRO/CMO oversight and/or auditing (GLP/GCP/GMP).
• Demonstrated knowledge of ICH (e.g., E6(R2)/E8(R1)/Q9(R1)), OECD GLP, FDA, EMA, EU Annex 11/21 CFR Part 11, and data integrity (ALCOA+).
• Effective communication and negotiation skills.

Responsibilities

• Oversee vendor lifecycle and governance, including qualification and risk-based monitoring.
• Support GxP audits of CROs/CMOs and ensure findings are tracked and reported.
• Contribute to QMS, deviation, CAPA processes for third parties.
• Maintain vendor KPIs/SLAs and governance forums with CAPA tracking.
• Collaborate with Clinical Operations, Nonclinical, CMC, Safety, Supply Chain, Procurement, Legal, and IT to embed quality requirements.
• Stay current with GxP regulations and drive continuous improvement.

Skills

GxP quality

Vendor oversight

Auditing

Regulatory knowledge

Communication

Negotiation

Cross-functional collaboration

Education

Bachelor’s degree in relevant scientific discipline

Job description

CSL Seqirus is seeking a Vendor/Supplier QA Auditor to oversee external partners supporting R&D and regulated activities, ensuring GLP/GCP/GMP/GVP compliance and data integrity.

You will lead the end-to-end vendor lifecycle, including due diligence, qualification, quality agreements, risk-based monitoring, CAPA handling, and continuous improvement, collaborating with Clinical, Nonclinical, CMC, Safety, Procurement, Legal and IT to enable reliable third-party delivery.