Apply on Employer Site

Day One Biopharmaceuticals · 21 hours ago

Associate Director, Quality Assurance - Biologics and ADC

United States

Full-time

Remote

Lead/Staff, Director/Executive

$180K/yr - $190K/yr

8+ years exp

Day One Biopharmaceuticals is focused on advancing first- or best-in-class medicines for childhood and adult diseases. The Associate Director, Quality Assurance, serves as the primary QA lead for Antibody-Drug Conjugate (ADC) and biologics programs, providing strategic and operational QA leadership across various phases of development.

BiopharmaBiotechnologyHealth CarePharmaceutical

No H1B

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

Qualification

QA leadershipBiologics developmentADC developmentRegulatory complianceGxP complianceAnalytical method validationRisk-based decision-makingCross-functional collaborationCommunication skillsNegotiation skillsLeadership skills