Associate Director, Quality Assurance & Quality Control

Associate Director, Quality Assurance & Quality Control
Company:
Actinium Pharmaceuticals, Inc. is a biopharmaceutical company developing targeted radiotherapies for patients with high unmet needs. Our vision is to build a fully integrated specialty oncology company built on our innovative R&D capabilities in targeted radiotherapy. Our pipeline includes both therapeutic radiopharmaceuticals utilizing Actinium-225 (Ac-225) and imaging agents utilizing Zirconium-89 (Zr-89), supporting our targeted alpha therapy platforms. Actinium strives to be the leader in targeted radiotherapy and to bring innovative medicines to patients.
Job Overview:
Actinium Pharmaceuticals is seeking an Associate Director, Quality Assurance & Quality Control in New York, NY. The Associate Director will help lead QA and QC activities supporting Actinium's radiotherapeutic pipeline, which is currently in Phase 1 development with planned advancement to Phase 2/3. This role will help oversee Quality Assurance at Actinium's CDMO partners and at its newly constructed internal manufacturing facility, and will oversee and establish Quality Control for both external partners and internal manufacturing. This role covers both therapeutic products (Ac-225) and imaging products (Zr-89), and works closely with Development, Manufacturing Operations, and Quality Control to ensure best practices and consistent delivery on company milestones.
This role reports to the Executive Director, Head of CMC
Key Responsibilities:
Quality Assurance:
Oversee QA support for GMP manufacturing at CDMO partners and at the newly constructed internal manufacturing facility, ensuring consistent quality oversight across both networks.
Support scale-up of quality systems and infrastructure to prepare the organization for the transition from Phase 1 to Phase 2/3 clinical development.
Manage batch record review and disposition, deviations, CAPAs, change controls, and product quality complaints across CDMO and internal manufacturing sites.
Support internal manufacturing facility start-up activities, including qualification, validation, and quality oversight readiness for GMP operations.
Ensure QA activities remain aligned with Actinium’s Quality System requirements, external regulations and the Quality Management Systems of CDMO partners.
Support vendor audits and Health Authority inspection readiness, including generation of responses and CAPAs as needed.
Quality Control:
Establish and oversee Quality Control operations and testing programs for both external CDMO partners and the internal manufacturing facility.
Oversee QC method transfer, qualification, and validation for radiotherapeutic-specific assays, including sterility, endotoxin, filter integrity testing, iTLC, HPLC, immunoreactive fraction (bead-based functional binding assay), visual appearance, radionuclidic identity, radionuclidic purity, radiochemical purity, and other typical radiotherapeutic release and characterization assays.
Oversee stability programs for mAb bulk drug substance and mAb-chelator intermediates.
Oversee drug product stability programs, accounting for the distinct stability requirements of radioactive therapeutic and imaging products driven by isotope half-life.
Ensure QC methods are fit-for-purpose and appropriately validated ahead of Phase 2/3 advancement.
Establish QC-related KPIs and metrics; identify and mitigate quality risks across the CDMO and internal manufacturing network.
Qualifications:
Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, Chemical Engineering, or related field); advanced degree preferred.
Minimum of 8 years of biopharmaceutical QA and/or QC experience, including experience in a GMP manufacturing environment.
Experience with radiopharmaceuticals/radiotherapeutics strongly preferred; familiarity with radionuclidic and radiochemical analytical methods required.
Experience overseeing QA and/or QC at CDMOs; hands-on experience supporting internal manufacturing facility start-up or technology transfer preferred.
Foundational knowledge of cGMP regulations and quality systems required (deviations, CAPAs, change control, complaints).
Experience with biologics (mAb) drug substance and drug product manufacturing and associated stability programs preferred.
Strong communication, organizational, and project management skills; ability to manage multiple priorities across internal and external sites.
Ability to build strong, trusting relationships and work effectively across a matrixed, cross-functional organization.
Travel:
This role may require up to 25% domestic travel to support CDMO and internal manufacturing site oversight.
Compensation:
Compensation will be commensurate with experience. Actinium offers competitive base salaries, performance bonuses, equity incentive plans, 401(K) with company matching and comprehensive health benefits.