CQA Vendor Oversight and Quality Assurance Lead (US)

The CQA Vendor Oversight and Quality Assurance Lead role will own 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

• Define and execute 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).
• Establish and assure upkeep of vendor KPIs/SLAs, quality dashboards, and governance forums for performance, risk, and remediation tracking.
• Lead periodic vendor reviews (e.g., QBRs) as appropriate, ensuring KPIs achieve target level, actions, and corrective and preventive actions (CAPAs) are implemented/verified to assure 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.
• Coordinate 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

• Lead risk 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.

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.

Travel: This role will include up to 50% travel