CQA Vendor Oversight and Quality Assurance Lead (US)

CQA Vendor Oversight And Quality Assurance Lead

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

• Vendor Lifecycle & Governance
• Inspections
• Quality Systems & Compliance
• Risk Management & Continuous Improvement
• Cross Functional Partnership
• Maintain and share knowledge of Regulations and 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.

Travel: This role will include up to 50% travel