Associate Director, Quality Assurance – Biologics and ADC
Day One Biopharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $180,000 - $190,000 per year
Job Level
About the role
- 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.
- Advises teams on what is required vs. optional at each phase: Phase 1, Phase 2, Phase 3.
- 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.
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.
Benefits
- Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
QA strategyquality planmethod validationanalytical control strategiesmethod qualificationrisk-based compliancespecification tighteningcomparability strategiesCAPA effectivenessbiologics assays
Soft skills
communicationnegotiationleadershipinfluencecross-functional collaborationstrategic oversightproblem-solvingdecision-makingguidanceevaluation
Certifications
BSMSPhD