Manager, Quality Operations

Obsidian Therapeutics·
Bedford, MA (Hybrid)
2w ago
Full-timeMidQuality AssuranceOncologyUnknownBachelors
$129K - $158K/yr

Description

You’ll be responsible for planning, coordinating, and executing critical quality initiatives that ensure compliance with regulatory requirements. You will oversee CDMO manufacturing and provide QA support for manufacturing operations including CMC and supply chain management. Your role includes managing lot disposition, quality investigations, and regulatory inspection readiness, along with facilitating quality issue resolutions and supporting development of quality metrics.

Requirements

Bachelor’s degree in Biology, Chemistry, Engineering, life sciences, or a related field, and 6+ years of relevant work experience (or M.S. and 4+ years). Familiarity with GMP regulations, quality system processes, and experience with CDMO manufacturing. Strong communication, planning, and relationship management skills.
Obsidian Therapeutics

Obsidian Therapeutics

BIOTECHNOLOGY

Cell & Gene Therapies

LocationMA - Cambridge
Employees51-200
Open Jobs7
OncologyCell and Gene TherapyBiotechCell and Gene Therapies
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Pipeline

OBX-115Phase 1/2