Senior Global Quality Auditor

4 weeks ago

Dublin, Ireland Alexion Pharmaceuticals Full time

This is what you will do:

The Senior Global Quality Auditor (GMP), Alexion Operations Audit, Central Quality Systems & Compliance (CQSC) has key responsibilities including auditing a great variety of GMP sites (internal and suppliers) ranging from biotechnology, material manufacturers, combination product, to distributors. You will have key responsibilities in the management of the Alexion GMP, GDP and Medical Device internal and supplier audit programs.

You will support, lead and report independent GMP audits in accordance with Alexion QMS and GMP regulations to assess the internal network and suppliers of Alexion, including contract manufacturers, warehouses, laboratories, quality systems. In addition, participate and lead compliance improvement projects within Alexion.

The incumbent will be responsible for supporting the business in management of the end-to-end process for audit lifecycle from planning, scheduling, conducting, reporting to closure, ensuring best practices are implemented and personnel are mentored in the audit management system and processes. The role also provides support to internal and external key-stakeholders by providing quality and compliance guidance.

You will be responsible for:

Performing sophisticated and fast paced domestic, regional and international audits of Alexion sites and suppliers of biologics, active pharmaceutical ingredients, finished drug products, or contracted services. 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 keep aware of trends and initiatives in quality assurance, GMP compliance, and inspections. Working closely with other QA colleagues to assure common understanding of developing interpretations of cGMP. Building and maintaining strong customer relationships with other functions whose activities overlap, influence or affect compliance and lead or participate in GxP audits/initiatives with other Alexion quality groups. Developing solutions to a diverse range of problems that require complex judgements, using highly developed levels of conceptual thought and analysis. Driving, role modeling and supporting a strong lean culture that promotes standardization, simplification and continuous improvement. Providing leadership and management to the Audit team, cascading messages and goals from senior management, managing and prioritizing team workload, and managing team performance. Maintaining an up-to-date global audit schedule and generating periodic metric reports suitable for viewing by and presentation to Senior Management/leadership. Managing the initiation, assignment, execution and close-out of all audit observations and related response actions. Contributing to the further development of the audit function by shaping the Alexion audit landscape through proposals and innovative solutions. People management responsibilities Up to 60% travel required.

You will need to have:

Bachelor’s Degree required, preferably within the life science area. 12+ years experience in a GMP/GDP/Medical Device related industry in a quality/compliance function is required, with strong Quality Management Systems knowledge. 5+ years GMP QA experience leading and conducting audits preferably with a biologics/combination product space. 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 communication skills Strong attention to details skills, with an ability to think higher-level when required Strong leadership skills People management skills Strong organizational skills Technical writing/ reporting skills Ability to multi-task and prioritize work Team-oriented approach to project management and problem resolution Ability to take on complex problems which require analysis and evaluation The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

Advanced Degree preferred, but not required. Experience with Quality Systems (e.g. Veeva Vault) is desirable.

Date Posted

06-Jun-2024

Closing Date

15-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

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