GxP Auditor

About The Job

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: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.

Position Summary

Fusion has opened a newly created role in Quality Assurance for a GxP Auditor. This position will focus on compliance within Fusion Pharmaceuticals internal systems, manufacturing, and the R&D organization while providing quality systems oversight in preparation for commercialization. The identified candidate will have experience with internal auditing of quality systems as well as vendor audits. This role will report to the Director of Supplier Quality and can be based out of either our Hamilton, Ontario or Boston, MA locations.

Responsibilities

Audit Planning and Execution

• Develop and Execute Audit Plans: Design and implement risk-based audit strategies for internal operations and external suppliers, ensuring alignment with GMP standards and regulatory requirements.
• Conduct Comprehensive Audits: Perform detailed audits across various departments, including Manufacturing, Quality Assurance, Quality Control, Microbiology, Facilities, and IT, to assess compliance with established procedures and regulatory guidelines.
• Communication and Escalation: Ensuring escalation to reporting manager and leadership of all critical concerns identified during the execution of audits.
  
  

Regulatory Compliance and Inspection Support

• Prepare for Regulatory Inspections: Assist in the preparation for inspections by regulatory bodies (e.g., FDA, Health Canada), ensuring all necessary documentation and corrective actions are in place.
• Support Inspection Activities: Participate in regulatory inspections, providing real-time support and addressing queries from inspectors to facilitate smooth evaluations.
• Monitor Regulatory Changes: Stay abreast of changes in regulatory requirements and industry standards, ensuring that audit practices remain current and compliant.
  
  

Audit Reporting and CAPA Management

• Document Audit Findings: Prepare detailed and accurate audit reports, highlighting non-conformances and areas for improvement.
• Develop Corrective and Preventive Actions (CAPAs): Collaborate with relevant departments to formulate effective CAPAs in response to audit findings, ensuring timely implementation and resolution.
• Monitor CAPA Effectiveness: Conduct follow-up audits to assess the effectiveness of implemented CAPAs and ensure sustained compliance.
  
  

Continuous Improvement and Training

• Identify Improvement Opportunities: Analyze audit results to identify trends and areas for continuous improvement within the quality management system.
• Provide Training and Guidance: Participate in the development of training sessions to staff on audit processes, regulatory requirements, and best practices to foster a culture of quality and compliance.
• Collaborate Across Departments: Work closely with cross-functional teams to promote quality awareness and ensure consistent application of quality standards throughout the organization.
  
  

Qualifications

Educational Background: Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field.

Professional Experience:Minimum of 5 years in pharmaceutical Quality Assurance, with at least 3 years of direct auditing experience in GMP environments.

Regulatory Knowledge: In-depth understanding of FDA and Health Canada regulations, with experience in sterile manufacturing (experience in radiopharmaceuticals is considered an asset).

Audit Expertise:Proven ability to conduct comprehensive audits, prepare detailed reports, and assess effective CAPAs.

Communication Skills: Strong written and verbal communication skills, with the ability to interact effectively at all levels of the organization.

Certifications: Certification in Quality Auditing (e.g., ASQ CQA) is considered an asset.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.

Fusion Pharmaceuticals is an equal opportunity employer that is committed to inclusive, barrier-free recruitment and selection processes, if contacted for an interview, please advise Human Resources if you require accommodation.

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.