Alexion Pharmaceuticals, Inc. · 10 hours ago
Sr. Global Quality Auditor
New Haven, CT
Full-time
Hybrid
Senior Level, Lead/Staff
12+ years expAlexion Pharmaceuticals, Inc. is a company focused on rare diseases, and they are seeking a Senior Quality Auditor for their Rare Disease Unit. The role involves auditing various GMP/GDP sites, supporting compliance and process improvement projects, and providing guidance to key stakeholders on quality and compliance matters.
BiotechnologyHealth CareMedicalTherapeutics
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)
Commutable to site at the ARDU New Haven, CT and Boston, MA facilities
Qualification
Required
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
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
Bachelor's Degree required, preferably at Master's level within the life science area
Preferred
5+ years GMP/GDP QA experience supporting or conducting audits (preferred). Audit experience preferably within the biologics area
Lead auditor training certification (preferred)
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
bloomberglaw.com
2025-12-20
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