Global Quality Ops Lead — Analytical QA

Abivax; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Abivax, a biotechnology company focused on improving patient lives, seeks an Associate Director, Global Quality Operations – Analytical QA in the United States. You will lead QA operations oversight of external QC testing for clinical and future commercial products, drive compliant specification development, and supervise Q-Ops staff to ensure regulatory alignment and product quality.

Ideal candidates have 10+ years in the field, strong cGMP/ICH/FDA/EMA knowledge, and experience with CMOs and

Qualifications

• Bachelor’s or Master’s degree in life sciences or related field; significant industry experience may substitute.
• Minimum 10+ years of industry experience, ideally from early clinical phases through commercial drug products.
• Strong knowledge of cGMP/ICH/FDA/EMA regulations and ability to defend Quality Operations policies during inspections.

Responsibilities

• Provide QA representation, guidance, leadership, and direction for external QC testing for clinical and commercial product release, Stability, analytical method development/transfer, and establishment of specifications.
• Manage and mentor Q-Ops staff, emphasizing teamwork, planning, follow-up and effective communication.
• Manage disposition processes for clinical/commercial products produced in contract manufacturing operations (CMO).
• Ensure quality system controls for distribution pending regulatory submissions and approvals.
• Lead cross-functional collaboration to implement GMP Quality Systems including disposition, vendor management, deviations, CAPA and change management.
• Review and approve validation protocols/reports, analytical test methods, and stability protocols/reports.

Skills

QA Leadership

cGMP/ICH/FDA/EMA

Regulatory Interactions

External QC Testing Oversight

Documentation & Records

Education

Bachelor’s or Master’s in life sciences

Tools

Veeva

Job description

Abivax, a biotechnology company focused on improving patient lives, seeks an Associate Director, Global Quality Operations – Analytical QA in the United States. You will lead QA operations oversight of external QC testing for clinical and future commercial products, drive compliant specification development, and supervise Q-Ops staff to ensure regulatory alignment and product quality.

Ideal candidates have 10+ years in the field, strong cGMP/ICH/FDA/EMA knowledge, and experience with CMOs and