Associate Director, Quality Assurance - Biologics and ADC

Day One Biopharmaceuticals(26 days ago)

RemoteFull TimeDirector$180,000 - $190,000Quality Assurance

About this role

The Associate Director, Quality Assurance is the primary QA lead for Antibody-Drug Conjugate (ADC) and biologics programs in early to mid-stage clinical development, providing strategic and operational QA oversight. The role ensures phase-appropriate GxP compliance and alignment with ICH and global regulatory expectations while preparing teams and CDMOs for inspection readiness. The position partners cross-functionally with CMC, Research, Tech Ops, Regulatory, and external vendors and reports to the Senior Director of Quality Assurance.

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Required Skills

QA Leadership
Regulatory Interpretation
Inspection Readiness
Specification Setting
Method Validation
Batch Disposition
Change Control
Deviation Management
CAPA Management
Risk Management

+7 more

Qualifications

BS in Life Sciences
MS in Life Sciences
PhD in Life Sciences

About Day One Biopharmaceuticals

dayonebio.com

Day One Biopharmaceuticals is a biopharma company developing targeted cancer therapies for patients of all ages, with a particular emphasis on bringing new medicines to both children and adults. The company positions itself as disrupting the traditional drug‑development model to accelerate delivery of precision therapies and include pediatric populations earlier. Day One focuses on translational, age‑inclusive approaches to advance programs through clinical development and regulatory pathways. Its mission is to shorten the time from discovery to patient access for effective oncology treatments.