Senior Manager / Auditor

Position Summary

The Senior Manager/Auditor, Alexion Operations Audit, Central Quality Systems & Compliance (CQSC) has key responsibilities for auditing a variety of GMP sites (internal and suppliers) ranging from biotechnology, material manufacturers, combination product, to distributors.

The Senior Manager/Auditor is responsible for supporting the business in conducting the end-to-end audit process from planning, conducting, reporting to closure, ensuring best practices are implemented, and personnel are mentored in the audit management system and processes. The Senior Manager/Auditor supports, leads and reports on independent audits in accordance with Alexion QMS and regulations/standards to assess the internal network and suppliers of Alexion, including contract manufacturers, warehouses and laboratories and the implementation of their quality systems.

In addition, this role participates in, and leads, compliance improvement projects within Alexion and provides support to internal and external key-stakeholders by providing quality and compliance guidance.

Principal Responsibilities

• Supporting and performing complex and timely audits of Alexion sites and suppliers of biologics, active pharmaceutical ingredients, finished drug products, or contracted services.
• Adherence to the global audit schedule and improving global audit metric results
• Conducting independent appraisals of quality and compliance systems within technically advanced manufacturing settings.
• Initiating and maintaining close contacts with regulatory agencies and/or industry/ professional organizations to maintain knowledge of trends and initiatives in quality assurance, compliance, and inspections.
• Working closely with other QA colleagues to assure common understanding of developing interpretations of cGMP/GDP.
• Building and maintaining strong customer relationships with other functions whose activities overlap, influence, or affect compliance.
• Driving, role modelling and supporting a strong lean culture that promotes standardization, simplification, and continuous improvement in Audit Performance.
• Support and lead inspection readiness activities for the function, as required.
• Significant travel is required as part of this role (mostly regional/local), when required.

Qualifications

• 12+ years’ experience in a GMP/GDP/Medical Device or related industry in a quality/compliance function is required, with strong Quality Management Systems knowledge.
• 5+ years GMP/GDP QA experience in oversight or conducting audits preferably within the biologics/combination product area.
• Thorough knowledge of applicable international GxP regulations and standards (e.g., GMP, GDP, Medical Device etc.).
• Ability to navigate and be successful in a fast-paced, cross-functional work environment.
• Excellent written and verbal communication skills.
• Strong attention to details skills, with an ability to think strategically.
• Strong leadership and organizational skills
• Technical writing/ reporting skills
• Ability to multi-task and prioritize work effectively.
• Team-oriented approach to project management and problem resolution
• The duties of this role are generally conducted in an audit environment. The Senior Auditor must be able to use a PC; engage in communications via phone, video, and electronic messaging; engage with auditees efficiently and effectively so as to maximise audit performance.
• The Senior Auditor must be able to collaborate with auditees and colleagues respectfully and maintain general availability during standard business hours.

Education

• Bachelor’s Degree required, preferably at master’s level within the life science area.
• Lead auditor training certification (preferred).

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.