Additional Information
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
Csl · Americas, Us-pa, King Of Prussia, Csl Behring