Job Title: Associate Director, External QualityLocation: Boston, MA Hybrid 3 days/weekFusion 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 trials. In 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 Conjugates is 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 company's 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:- Bachelor's degree in pharmacy, Chemistry, Biology, Engineering, or related scientific field required; advanced degree or equivalent experience preferred.
- 10-12 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, Q8-Q10, 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.
