Fusion Pharmaceuticals
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 risk‑based audit plans for internal operations and external suppliers, ensuring alignment with GMP standards and regulatory requirements.
Conduct detailed audits across departments such as Manufacturing, Q.A., Q.C., Microbiology, Facilities, and IT to assess compliance with procedures and regulations.
Escalate critical audit findings to management and leadership for timely resolution.
Regulatory Compliance and Inspection Support
Assist in preparation for regulatory inspections (FDA, Health Canada) by ensuring documentation and corrective actions are in place.
Participate in inspections, providing real‑time support and addressing inspectors’ queries.
Monitor regulatory changes and industry standards to keep audit practices current and compliant.
Audit Reporting and CAPA Management
Prepare detailed audit reports highlighting non‑conformances and improvement opportunities.
Collaborate with relevant departments to formulate effective CAPAs and ensure timely implementation.
Conduct follow‑up audits to assess CAPA effectiveness and sustain compliance.
Continuous Improvement and Training
Analyze audit results to identify trends and opportunities for continuous improvement within the QMS.
Develop and deliver training sessions on audit processes, regulatory requirements, and best practices.
Collaborate across departments to promote quality awareness and consistent application of standards.
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; experience in sterile manufacturing (radiopharmaceuticals 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, with the ability to interact effectively at all organizational levels.
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 orientation, 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 you are contacted for an interview, please advise Human Resources if you require accommodation.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Accounting/Auditing and Finance
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Responsibilities
Audit Planning and Execution
Develop and execute risk‑based audit plans for internal operations and external suppliers, ensuring alignment with GMP standards and regulatory requirements.
Conduct detailed audits across departments such as Manufacturing, Q.A., Q.C., Microbiology, Facilities, and IT to assess compliance with procedures and regulations.
Escalate critical audit findings to management and leadership for timely resolution.
Regulatory Compliance and Inspection Support
Assist in preparation for regulatory inspections (FDA, Health Canada) by ensuring documentation and corrective actions are in place.
Participate in inspections, providing real‑time support and addressing inspectors’ queries.
Monitor regulatory changes and industry standards to keep audit practices current and compliant.
Audit Reporting and CAPA Management
Prepare detailed audit reports highlighting non‑conformances and improvement opportunities.
Collaborate with relevant departments to formulate effective CAPAs and ensure timely implementation.
Conduct follow‑up audits to assess CAPA effectiveness and sustain compliance.
Continuous Improvement and Training
Analyze audit results to identify trends and opportunities for continuous improvement within the QMS.
Develop and deliver training sessions on audit processes, regulatory requirements, and best practices.
Collaborate across departments to promote quality awareness and consistent application of standards.
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; experience in sterile manufacturing (radiopharmaceuticals 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, with the ability to interact effectively at all organizational levels.
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 orientation, 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 you are contacted for an interview, please advise Human Resources if you require accommodation.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Accounting/Auditing and Finance
#J-18808-Ljbffr