Associate Director, Quality Control

Responsibilities: Serve as QC Lead and primary QC point of contact for biologics programs and participate in product teams and governance forums Develop and maintain phase-appropriate end-to-end QC strategies for biologics (drug substance, drug product, intermediates, and materials) Own or oversee specifications and analytical methods Provide QC oversight for testing at internal labs, CMOs/CDMOs; establish governance, metrics, escalation, and testing-network strategies Provide scientific and quality guidance for deviations, out-of-spec results, method issues, stability trends, and investigations Offer QC SME input for CMC regulatory content, health-authority interactions, inspections, and readiness activities Lead cross-program QC governance and harmonization initiatives across modalities Lead, coach, and develop QC professionals and matrix teams Support department strategy, portfolio and resource prioritization, budgeting, and oversight of external labs and vendors Travel domestically and internationally as needed to support activities

Key requirements: Ph.D. with 2+ years of experience OR MS with 8+ years OR BS with 10+ years industrial experience Extensive experience in biopharmaceutical QC, analytical development, and related technical quality functions with biologics focus Experience developing analytical control strategies, specifications, method qualification/validation, transfer, stability, comparability, reference standards, and lifecycle management Experience supporting complex clinical programs and regulatory submissions, including launch readiness and lifecycle management Experience providing oversight of CMOs/CDMOs/CROs and contract testing laboratories; investigations and issue resolution Proven leadership of people and matrix teams, influencing senior stakeholders in a cross-functional setting Experience authoring/reviewing CMC regulatory content and supporting regulatory-readiness activities Knowledge of current Good Manufacturing Practices, data integrity, and global regulatory expectations for biologics Strong communication and executive-level presentation skills Collaboration, negotiation, and influencing without direct authority Strategic thinking and independent judgment Biologics characterization and testing knowledge (physicochemical, biochemical, microbiological) Phase-appropriate analytical development, control strategy, specifications, comparability, stability, method validation/transfer Analytical lifecycle management and regulatory readiness for analytic methods