Senior Specialist, Quality Operations
About The Position
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 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 execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant, brand new radio conjugate manufacturing facility to meet the demand for our growing pipeline of RCs. The Senior Specialist, Quality Operations ensures day-to-day quality oversight of manufacturing, packaging, testing, and distribution activities. The role executes quality system processes, provides on-the-floor support, and drives robust investigations and CAPA to protect product quality, patient safety, and regulatory compliance. This position partners closely with Operations, QC, Supply Chain, Engineering, and Regulatory to maintain right-first-time execution and continuous improvement.
Requirements
- Bachelor’s degree in life sciences, engineering, pharmacy, or related field; advanced degree is a plus.
- 4–7+ years in quality operations within manufacturing or laboratory environments; experience in regulated industries preferred.
- Strong knowledge of QMS, deviations/CAPA, change control, batch record review, and audit/inspection processes; familiarity with validation, data integrity, and statistical trending tools; proficiency with electronic QMS/LIMS/ERP and MS Office/Power BI.
- Experience in an aseptic GMP manufacturing environment is an asset
- Knowledge of FDA 21 CFR 210/211, EU GMP/Annexes, ICH Q9/Q10, PIC/S.
- Detail orientation, problem-solving, clear communication, ability to influence without authority, collaboration, and resilience under time pressure.
Responsibilities
- Provide on-the-floor QA presence for manufacturing and packaging; verify adherence to procedures, critical parameters, and line clearance; support start-up, interventions, and batch record execution.
- Lead or facilitate timely investigations using root cause tools (5-Why, Ishikawa, FMEA); define corrective/preventive actions; perform effectiveness checks; trend issues and drive systemic fixes.
- Author, assess, and approve changes to processes, equipment, materials, and documentation; ensure risk assessments and validation impacts are addressed.
- Operate QMS elements including SOPs, training, complaints, supplier quality, stability, APR/PQR inputs, and metrics; ensure records are complete and audit ready.
- Oversee aseptic behaviors, gowning, environmental monitoring, sterilization and media fill readiness; review EM trends and investigate excursions.
- Coordinate with QC for testing review, OOS/OOT investigations, method or instrument changes, and data integrity checks.
- Support incoming material release, sampling plans, and supplier notifications; participate in supplier qualifications and audits as needed.
- Prepare areas and documentation for internal/external audits; host tours, answer inquiries, and manage observation responses; ensure sustained readiness.
- Deliver or reinforce GMP and SOP training; coach operators on quality expectations; promote a right-first-time culture.
- Analyze defects and deviation trends; implement standard work, mistake-proofing, and process capability improvements; contribute to quality KPIs and dashboards.
- Ensure ALCOA+ principles in all records; review electronic systems for permissions, audit trails, and validated state; enforce good documentation practices.
- Support tech transfers, scale-up, equipment qualification, and validation activities; provide quality input to project teams.
Benefits
- Annual base salary for this position ranges from 88,296.80 to 115,889.55.
- Annual Variable Pay Bonus/Short Term Incentive opportunity
- Eligibility to participate in our equity-based long-term incentive program (if applicable to role).
- Competitive Flex Benefits & Retirement Savings Program
- 4 weeks’ paid vacation
- Annual Personal Days
- Contract Benefits Program (for Fixed Term Contract/Temporary positions excluding students)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
