Quality Systems Strategy Lead — GMP Biotech

Lever, Inc.

Massachusetts

Hybrid

USD 150,000 - 190,000

Full time

2 days ago

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Job summary

Landmark Bio seeks an Associate Director, Quality Systems to lead strategy and continuous improvement of the Quality Management System across early clinical to late-stage development. You will own the quality manual, change control, deviations, CAPA, training, supplier quality and risk management, while enabling timely audit responses and a strong quality culture.

You will build and guide a high-performing team, partner with Operations, QC, Process Development and IT, and drive risk-based

Qualifications

Bachelor’s degree in STEM (biology, chemistry or engineering).
8+ years in Quality within GMP biotech manufacturing (cell/gene therapy preferred).
5+ years of effective management and leadership experience.

Responsibilities

Own strategy, design and continuous improvement of the Quality Management System across development phases.
Establish and maintain quality manual, policies and procedure hierarchy.
Lead audit readiness and supplier/client/internal audits, including CAPA follow-up.
Define, trend and report key quality metrics to identify risks and improvements.
Build and develop a high-performing Quality Systems team and oversee Change Control Board.
Foster a Culture of Quality and ensure compliance with regulatory guidance.