Senior Specialist, Quality Operations

Job Title: Senior Specialist, Quality Operations

Location: Hamilton, Ontario

Onsite 5 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 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.

Position Summary

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. This position reports to AD, Quality Operations.

Key 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.

Qualifications

• 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.
• >5% travel required.

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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 AZCHumanResources@astrazeneca.com.

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AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

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