Alexion JapanSenior Quality Auditor, Alexion Operations Audit

Position Summary

The Senior Quality Auditor at Alexion Rare Disease Unit (ARDU) has key responsibilities for auditing a variety of GMP/GDP sites (internal and external suppliers) used for commercial and development projects. The manufacturing sites audited range from biotechnology combination products medical devices raw material to fill finish facilities. Laboratory and distributor facilities are also audited.

The auditor will assess the internal network and suppliers of ARDU by supporting the end-to-end audit process including planning leading reporting and closure of audits in accordance with ARDUs Quality Management System regulations and industry best practices.

This role supports compliance and process improvement projects within ARDU and provides support to internal and external key-stakeholders by providing quality and compliance guidance.

Principal Responsibilities

• Ensures compliance with regulatory and internal requirements by leading and supporting the complete audit lifecycle inclusive of planning execution reporting review and 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.
• Maintaining supporting and adhering to the global audit schedule and generating periodic metric reports suitable for viewing by and presentation to Management/ leadership/ External parties (e.g. regulators).
• 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.
• Partnering with ARDU stakeholders for the effective execution of audits.
• Building and maintaining strong customer relationships with other functions whose activities overlap influence or affect compliance.
• Support and lead key and senior conversations with key stakeholders on all audit related topics such as metrics/queries/actions as required.
• Providing leadership to the Audit team.
• Working closely with other QA colleagues to assure common understanding of developing interpretations of cGMP/GDP.
• Developing solutions to a diverse range of problems that require complex judgements using highly developed levels of conceptual thought and analysis.
• Driving role modelling and supporting a strong lean culture that promotes standardization simplification and continuous improvement in Audit Performance.
• Supports inspection readiness activities for the function as required.
• 60% travel required (mostly regional/locally America regions).

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 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 etc.) inclusive of FDA and EU regulations.
• 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 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 Auditor must be proficient in the use of complex electronic systems and a quick learner of new applications and be able to engage in communications via phone video and electronic messaging; engage with auditees efficiently and effectively so as to maximize audit performance.
• The Auditor must be able to collaborate with auditees and colleagues respectfully and maintain general availability during standard business hours.

Education

• Bachelors Degree required preferably at Masters level within the life science area.
• Lead auditor training certification (preferred).

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.