Associate Director, External Quality

Job Title: Associate Director External Quality

Location: Boston MA

Hybrid 3 days/week

Fusion Pharmaceuticals a member of the AstraZeneca Group is a clinical-stage oncology company focused on developing next generation radio conjugates (RCs) as precision medicines. Fusion has multiple pipeline programs entering early FIH addition Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support these programs Fusion has a fully operational radio conjugate manufacturing facility. It is brand new and GMP compliant to meet the demand for our growing pipeline of RCs.

The Role:

AD External Quality Radio Conjugatesis accountable for end-to-end Quality oversight of external manufacturing partners contract development and manufacturing organizations (CDMOs) suppliers and testing laboratories supporting commercial and/or late-stage clinical products. The role ensures products and processes supplied by external partners meet applicable cGxP requirements marketing authorization commitments and company standards. This leader drives proactive quality risk management addressing customer concerns and resolution and continuous improvement across the external network. This position will report to the Head of Radiopharmaceutical Quality.

Responsibilities:

• External Partner Oversight: Provide strategic and operational Quality oversight for assigned CDMOs/CMOs testing labs and critical suppliers across drug substance drug product packaging/labeling and distribution. Establish quality governance performance metrics and relationship management routines.
• Compliance and QMS: Ensure partner adherence to cGMP/cGDP/cGLP ICH and relevant regional regulations (e.g. FDA EMA MHRA PMDA). Maintain robust Quality Agreements and ensure effective implementation of the companys Quality Management System elements at partners (deviation/CAPA change control complaints recalls batch release training data integrity and document control).
• Technical and Lifecycle Support: Guide validation/qualification (process cleaning methods equipment) technology transfers and change management. Review/approve master and completed batch records specifications method transfers and validation protocols/reports.
• Risk Management: Lead risk assessments (FMEA HACCP ICH Q9 principles) to identify and mitigate quality and supply risks. Drive proactive detection and prevention strategies trend analysis and management reviews.
• Investigations and CAPA: Oversee and approve quality investigations for deviations OOS/OOT complaints and stability issues from partners. Ensure high-quality root cause analysis and effective sustainable CAPAs with timely closure and verification of effectiveness.
• Regulatory Readiness: Ensure partners are inspection ready. Lead or support health authority inspections and partner audits; manage responses commitments and follow-up actions. Contribute to regulatory submissions (CMC quality sections) and post-approval changes.
• Metrics and Governance: Define and monitor Supplier benchmarks (right-first-time deviation rate cycle times complaint rate timely CAPA audit/inspection outcomes). Advance significant quality or supply risks through internal governance and lead cross-functional resolution.
• Cross-Functional Leadership: Partner closely with Technical Operations Manufacturing Supply Chain CMC Procurement and Quality Control to ensure reliable supply and compliant operations. Provide quality input to sourcing decisions business continuity and network strategy.
• Continuous Improvement: Champion guidelines digital/analytics enablement and quality culture across the external network. Drive simplification and standardization of processes to improve compliance and efficiency.
• People and collaborator management: Provide matrix leadership to site-facing quality teams and subject matter experts; mentor partners on expectations and standards.

Qualifications:

• Bachelors degree in pharmacy Chemistry Biology Engineering or related scientific field required; advanced degree or equivalent experience preferred.
• 1012 years in pharmaceutical/biotech Quality or Manufacturing with significant experience overseeing external manufacturing/testing partners. Demonstrated leadership in commercial and/or late-stage clinical operations.
• Strong knowledge of cGMP for drug substance and drug product ICH guidelines (Q7 Q8Q10 Q12) and data integrity principles; familiarity with GDP for distribution oversight. Experience with biologics and/or small molecules; cell/gene therapy experience is a plus depending on portfolio.
• Hands-on experience with deviation/investigation management CAPA change control complaints/recalls validation stability and batch disposition. Comfortable with electronic QMS and quality documentation systems.
• Proven track record leading external audits and supporting or hosting health authority inspections with successful outcomes.
• Experience in technology transfers PPQ method transfers cleaning/process validation and control strategy implementation.
• Proficiency in risk assessment tools and using data/metrics to drive decisions and continuous improvement.
• Strong influencing and relationship-building skills with external partners; crisp written and verbal communication; ability to lead through ambiguity prioritize effectively and escalate with clarity. Vendor negotiation and conflict resolution experience beneficial.
• >20-30% travel required.

Preferred Experience

• Prior radio conjugate experience
• Prior responsibility for multiple CMOs/CDMOs across regions and modalities (DS DP packaging/labeling).
• Experience integrating quality considerations into sourcing and contracting; drafting/negotiating Quality Agreements.
• Familiarity with serialization/traceability Annex 1 for sterile manufacturing (if applicable) and computerized system compliance (CSV/CSA).
• Knowledge of environmental monitoring contamination control strategies and aseptic processing for sterile products.
• Exposure to statistical sampling SPC and continued process verification.

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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment assessment and selection process and may be requested by emailing.

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