Sr. Global Quality Auditor

Position Summary

The Senior Quality Auditor at Alexion Rare Disease Unit (ARDU) is responsible for auditing a variety of GMP/GDP sites—including biotechnology, combination products, medical devices, raw material to fill‑finish facilities—as well as laboratory and distributor facilities. The auditor will assess the internal network and suppliers of ARDU by supporting the end‑to‑end audit process (planning, leading, reporting, and closure) in accordance with ARDU’s Quality Management System, regulations, and industry best practices.

This role also supports compliance and process improvement projects within ARDU and provides quality and compliance guidance to internal and external stakeholders.

• Ensure compliance with regulatory and internal requirements by leading and supporting the complete audit lifecycle—including planning, execution, reporting, review, acceptance of responses, and audit closure—for complex audits of ARDU sites and suppliers of biologics, active pharmaceutical ingredients, finished drug products, and contracted services.
• Maintain and support the global audit schedule, generating periodic metric reports suitable for presentation to management, leadership, and external parties (e.g., regulators).
• Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings.
• Initiate and maintain close contacts with regulatory agencies and industry/professional organizations to keep knowledge of trends and initiatives in quality assurance, compliance, and inspections.
• Partner with ARDU stakeholders for the effective execution of audits.
• Build and maintain strong customer relationships with other functions whose activities overlap, influence, or affect compliance.
• Support and lead key and senior conversations with stakeholders on all audit‑related topics such as metrics, queries, and actions as required.
• Provide leadership to the audit team.
• Work closely with other QA colleagues to assure common understanding of developing interpretations of cGMP/GDP.
• Develop solutions to a diverse range of problems that require complex judgments using highly developed levels of conceptual thought and analysis.
• Drive, role‑model, and support a strong lean culture that promotes standardization, simplification, and continuous improvement in audit performance.
• Support inspection readiness activities for the function, as required.
• Travel: 60% required, primarily regional/locally within the Americas.
• Commute to ARDU sites in New Haven, CT, and Boston, MA.

• 12+ years’ experience in a GMP/GDP/Medical Device or related industry in a quality/compliance function, with strong Quality Management Systems knowledge.
• 5+ years’ GMP/GDP QA experience supporting or conducting audits (preferred). Audit experience preferably within the biologics area.
• Thorough knowledge of applicable international GxP regulations and standards (e.g., GMP, GDP, Medical Device, FDA, EU).
• Ability to navigate and succeed in a fast‑paced, cross‑functional work environment.
• Excellent written and verbal communication skills.
• Strong attention to detail, with the ability to think strategically.
• Strong organizational skills.
• Technical writing and reporting skills.
• Ability to multi‑task and prioritize work effectively.
• Team‑oriented approach to project management and problem resolution.
• Proficiency with complex electronic systems and effective communication via phone, video, and electronic messaging during standard business hours.
• Respectful collaboration with auditees and colleagues.

• Bachelor’s Degree required;
  Master’s degree preferred in a life science area.
• Lead auditor training certification preferred.

Alexion Pharmaceuticals, Inc. is an equal employment opportunity employer and encourages all qualified applicants, regardless of protected characteristics, to apply. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.