GxP Auditor

Job Description

<p><p>Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes several RC programs and collaboration efforts; Fusion has a GMP-compliant radiopharmaceutical manufacturing facility to support the growing pipeline.</p><p><strong>Position Summary</strong></p><p>Fusion has opened a newly created role in Quality Assurance for a GxP Auditor. This position will focus on compliance within Fusion’s internal systems, manufacturing, and the R&D organization while providing quality systems oversight in preparation for commercialization. The candidate will have experience with internal auditing of quality systems as well as vendor audits. This role reports to the Director of Supplier Quality and can be based in Hamilton, Ontario or Boston, MA.</p><h3>Responsibilities</h3><ul><li>Audit Planning and Execution: Develop and implement risk-based audit strategies for internal operations and external suppliers, ensuring alignment with GMP standards and regulatory requirements.</li><li>Conduct Comprehensive Audits: Perform audits across Manufacturing, Quality Assurance, Quality Control, Microbiology, Facilities, and IT to assess compliance with procedures and regulatory guidelines.</li><li>Communication and Escalation: Escalate critical concerns identified during audits to the reporting manager and leadership.</li></ul><h3>Regulatory Compliance and Inspection Support</h3><ul><li>Prepare for Regulatory Inspections: Assist in inspection readiness with regulatory bodies (e.g., FDA, Health Canada), ensuring documentation and corrective actions are in place.</li><li>Support Inspection Activities: Participate in inspections, addressing inspector queries to facilitate smooth evaluations.</li><li>Monitor Regulatory Changes: Stay current on regulatory requirements and industry standards to keep audit practices compliant.</li></ul><h3>Audit Reporting and CAPA Management</h3><ul><li>Document Audit Findings: Prepare detailed audit reports highlighting non-conformances and improvement opportunities.</li><li>Develop CAPAs: Collaborate with departments to formulate effective corrective and preventive actions with timely implementation.</li><li>Monitor CAPA Effectiveness: Conduct follow-up audits to verify sustained CAPA effectiveness.</li></ul><h3>Continuous Improvement and Training</h3><ul><li>Identify Improvement Opportunities: Analyze audit results to identify trends and areas for quality management system improvement.</li><li>Provide Training and Guidance: Support training sessions on audit processes, regulatory requirements, and best practices to foster a culture of quality and compliance.</li><li>Collaborate Across Departments: Work with cross-functional teams to promote quality awareness and consistent quality standard application.</li></ul><h3>Qualifications</h3><ul><li>Educational Background: Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field.</li><li>Professional Experience: Minimum of 5 years in pharmaceutical Quality Assurance, with at least 3 years of direct auditing experience in GMP environments.</li><li>Regulatory Knowledge: In-depth understanding of FDA and Health Canada regulations; experience in sterile manufacturing (radiopharmaceuticals experience is an asset).</li><li>Audit Expertise: Ability to conduct comprehensive audits, prepare reports, and assess CAPA effectiveness.</li><li>Communication Skills: Strong written and verbal communication, with ability to interact at all organizational levels.</li><li>Certifications: Quality Auditing certification (e.g., ASQ CQA) is an asset.</li></ul><p>All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.</p><p>Fusion Pharmaceuticals is an equal opportunity employer committed to inclusive, barrier-free recruitment and selection processes. If you require accommodation for an interview, please advise Human Resources.</p><h3>Seniority level</h3><p>Mid-Senior level</p><h3>Employment type</h3><p>Full-time</p><h3>Job function</h3><p>Quality Assurance</p></p> #J-18808-Ljbffr