GLP Vendor Oversight and QA 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

The Vendor/Supplier QA Auditor role will support the quality oversight of external partners supporting R&D and regulated activities (e.g., CROs, CMOs, laboratories, technology vendors). Lead the end-to-end vendor lifecycle—due diligence, qualification, quality agreements, risk based monitoring, issue management, and continuous improvement—ensuring adherence to GLP/GCP/GMP/GVP, data integrity and applicable regulations. This role partners closely with Clinical, Nonclinical, CMC, Safety, Procurement, Legal, and IT to enable compliant, reliable delivery from third parties.

Main Responsibilities and Accountabilities

1 Vendor Lifecycle & Governance

Provide input to R&D/Technical customers on risk-based vendor qualification and requalification strategies (paper assessments, remote/onsite diligence assessments, performance reviews).

In collaboration with R&D/Technical/Legal and QA Functional teams contribute to drafting, negotiating, and maintain Quality Agreements aligned to master service agreements (roles/responsibilities, quality standards, change control, deviation management, data integrity, and inspection support).

Maintain vendor KPIs/SLAs, quality dashboards, and governance forums for performance, risk, and remediation tracking.

Prepare periodic vendor reviews (e.g., QBRs) as appropriate, ensuring KPIs achieve target level, actions, and corrective and preventive actions (CAPAs) are implemented/verified to assess the overall health of the relationship.

2 Inspections

Support planning of routine GxP audits of CROs, CMOs, labs, and system/service providers; ensuring findings are classified, graded, and reported internally and externally.

Liaise with Vendors/Suppliers to assure corrective and preventative CAPA's are defined and fit-for-purpose. Perform follow up effectiveness checks.

Support inspection readiness and provide front/backroom support when third party services are in scope, support development of storyboards.

Maintain auditee scheduling, auditor qualification, and audit program metrics.

3 Quality Systems & Compliance

Ensure vendor practices meet GLP/GCP/GMP/GVP, ICH, OECD, ISO, and data integrity principles (ALCOA+) as well as other function specific guidelines, regulations, standards.

Provide input to deviation, complaint, change control, and CAPA processes involving third parties; participate in root cause analysis where appropriate.

Contribute to the Quality Management System (QMS)—procedures, templates, and training—for third party oversight.

4 Risk Management & Continuous Improvement

Maintain risk logs and assessments (e.g., risk registers, FMEA) to prioritize controls and monitoring frequency for specific vendors/suppliers.

Drive quality improvements with vendors (process robustness, right first time (cycle time reduction, etc.).

Analyze trends (audit findings, deviations, complaints) and present management reviews with actionable insights.

5 Cross Functional Partnership

Collaborate with Clinical Operations, Nonclinical, CMC, Safety, Supply Chain, Procurement, Legal, and IT to embed quality requirements in scopes of work and contracts.

Provide guidance during technology transfers, method validations, sample handling, and data flows between sponsor and vendors.

Act as CSL Person-in-Plant as appropriate to provide contemporaneous quality support to CSL specific vendor operations.

Train internal stakeholders on third party quality expectations and best practices.

6 Maintain and share knowledge of Regulations and Requirements

Stay current and up to date with GxP regulations and requirements related to audit management as well as industry/regulatory trends in this area.

Identify and/or create new requirements to ensure a high level of quality and communicate internally.

Position Qualifications and Experience Requirements

Education

Bachelor’s degree in relevant scientific discipline

Experience

3+ years of GxP quality experience with direct vendor/CRO/CMO oversight and/or auditing (GLP/GCP/GMP).

Demonstrated knowledge of one or more of the following 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.

Competencies

Ability to work with limited supervision and with multinational teams and external suppliers speaking different languages.

Strong analytical and demonstrated problem solving skills, excellent interpersonal/communication/influencing/negotiation skills, and excellent organizational skills with respect to planning / tracking and timelines.

Demonstrated knowledge of QMS implementation and regulatory frameworks.

A strong understanding of the requirements for Quality Assurance in relevant GxP discipline.

Experience in audit/inspection management and processes.

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement

Watch our On the Front Line video to learn more about CSL Seqirus