Associate Director, Quality Assurance - Biologics and ADC

Day One Biopharmaceuticals•Brisbane, CA

1d•Remote

About The Position

ASSOCIATE DIRECTOR, QUALITY ASSURANCE – BIOLOGICS & ADC At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one’ to the future they’ve envisioned. POSITION SUMMARY: The Associate Director, Quality Assurance, serves as the primary QA lead for Antibody-Drug Conjugate (ADC) and biologics programs in early and mid-stage development (Phases 1–3). This role provides strategic and operational QA leadership across specifications setting, analytical method validation, batch disposition, change control, and deviation/CAPA management. The incumbent ensures phase-appropriate GxP compliance, aligns development activities with ICH Q5/Q6/Q7/Q8/Q9/Q10 expectations, and drives risk-based decision-making that supports both development agility and regulatory readiness. This role partners cross-functionally with CMC, Research, Tech Ops, Regulatory, and external CDMOs to ensure quality by design, data integrity (ALCOA+), and end-to-end traceability throughout the ADC development lifecycle.This position will report to the Senior Director, Quality Assurance. This position has the potential to be fully remote. Travel up to 20% will be required for in person meetings.

Requirements

BS/MS/PhD in life sciences or related discipline.
8+ years of QA experience, with at least 5 years in biologics or ADC development.
Demonstrated expertise with ICH, 21 CFR Parts 210/211, 600–680, EMA biologics guidelines, and global clinical development expectations.
Proven ability to set quality strategy, influence cross-functional teams, and make phase-appropriate compliance decisions.
Deep understanding of biologics/ADC manufacturing, conjugation, analytics, and CMC development.
Experience regulatory interactions, and inspection readiness.
Excellent communication, negotiation, and leadership skills required for matrix collaboration.

Responsibilities

Functions as program QA owner for ADC and biologics assets, establishing the QA strategy and quality plan across Phases 1–3.
Provides interpretation of FDA/EMA/ICH biologics and ATMP guidance, ensuring development activities are compliant, risk-based, and phase-appropriate.
Anticipates regulatory expectations and drives inspection readiness across internal teams and CDMOs.
Guides teams on phase-specific requirements (e.g., specification tightening, method validation depth, stability expectations, comparability strategies).
Provides strategic QA oversight for method qualification, validation, transfer, and ongoing performance assessment for biologics and ADC-specific assays (e.g., DAR, conjugation profile, potency).
Ensures analytical control strategies are aligned with QbD principles and development phase expectations.
Owns end-to-end QA oversight of drug substance, intermediates, payloads, linkers, conjugation steps, and drug product batches.
Ensures batch record packages from CDMOs are complete, compliant, and meet internal quality standards before disposition.
Provides high-level guidance on complex deviations and investigations, evaluating scientific adequacy, true root cause, and effectiveness of CAPAs.
Assesses and approves change controls involving process changes, analytical methods, raw materials, and manufacturing sites.
Advises teams on what is required vs. optional at each phase: Phase 1: Foundational specifications, qualified methods, essential stability, fit-for-purpose characterization; rapid but controlled changes. Phase 2: Method validation, increasing specification tightness, comparability expectations, enhanced process understanding. Phase 3: Validation readiness, process performance qualification strategy, commercial-level control strategy convergence.
Ensures risks, data gaps, and regulatory impacts are identified and communicated early.
Serves as senior QA representative on CMC and Development Teams, driving quality risk assessments and program decision-making.
Leads QA governance of CDMO relationships, oversees audit planning, evaluates vendor responses, and escalates systemic issues.