Specialist, Global Quality Assurance

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Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary
The Global QA Specialist at Alira Health supports the development, implementation, and continuous improvement of quality systems across Alira Health's global operations, including Research and Clinical Development (RCD), Real World Solutions (RWS), and Patient-Centric Technology (PCT). This role is responsible for ensuring compliance with applicable regulatory standards (e.g., ICH GCP, GDPR, ISO 27001, 21 CFR Part 11), internal procedures, and industry best practices. The Global QA Specialist works cross-functionally with internal stakeholders and external partners to support audits, CAPAs, vendor qualification, and quality documentation.

Job Description
ROLE

The Global Quality Assurance Specialist works closely with the Quality Assurance (QA) team and all business units to support the implementation and maintenance of the quality management system (QMS), the management of internal and external audits, and training compliance.

KEY RESPONSABILITIES

Tactical

• Collaborate in the preparation or review of internal documents and reports required by Alira Health procedures such as policies, procedures, quality events, validation documentation, and other regulated records.
• Document and track quality events.
• Provide QA support client audits, including documentation preparation and response tracking.
• Conduct internal and vendor audits, and support external audits and inspections by preparing documentation, coordinating logistics, and tracking audit responses.
• Assist in the development and maintenance of policies, procedures, and other QMS controlled records.
• Track training compliance, review training records, and ensure timely onboarding of new personnel in quality-related topics.
• Support computer system validation documentation reviews for GxP-relevant systems.
• Provide interpretation of regulatory requirements and offers recommendations regarding pathways to compliance.
• Participate in, or lead, meetings with key stakeholders.

• Participate in the implementation of the global Quality Policy and QMS.
• Coordinate vendor qualification and due diligence activities: risk assessments, due diligence, distribution and follow-up of qualification questionnaires, and audit planning.
• Support internal audit programs, including scheduling, execution, reporting, and follow-up on corrective actions.
• Partner with stakeholders to ensure quality oversight and ongoing compliance in active studies technology platforms, and service providers.
• Contribute to quality metrics tracking, trend analysis, quality risk management, and Quality Management Reviews (QMRs) to identify areas for improvement.
• Collaborate in the implementation of risk mitigation strategies based on quality management review outcomes.
• Maintain document control processes and ensure timely periodic review of controlled documents.
• Participate in the preparation for, hosting of, Sponsor and ISO surveillance audits and regulatory inspections.
• Support the investigation, documentation, and response to quality issues and audit findings.
• Contribute to process improvement initiatives and harmonization efforts across global sites.
• Responds to requests and emails promptly and efficiently.
• Performs additional duties as assigned.

• Support the development and deployment of a global quality strategy aligned with corporate goals and regulatory expectations.
• Support the implementation of risk-based quality management approaches across business units.
• Participate in strategic quality and continuous improvement initiatives aimed at harmonizing processes, reducing non-compliance, facilitating risk-based quality management, strengthening inspection readiness, and implementing data integrity programs.
• Contribute to the integration of acquired entities or new platforms into Alira Health's quality framework.
• Monitor and assess applicable regulatory changes (e.g., ICH E6(R3), GDPR, ISO 27001) and provide input on policy or procedural updates.
• Promote a strong quality culture and awareness throughout the organization through training, communication, and quality advocacy.
• Stay informed of regulatory updates and industry trends, proactively assessing their impact on Alira Health operations and policies.
• Act as a point of contact for assigned studies or business units, providing guidance on regulatory and procedural compliance.
• Adhere to, and ensure compliance with, applicable laws, regulations, guidelines, standards, and company policies.
• Propose strategic solutions to issues prior to escalation.

• BS/BA in Life Sciences from an undergraduate program or equivalent experience.
• A minimum of 3 years of relevant experience in Quality Assurance, pharmaceutical, biotechnology and/or CRO industry.
• Experience working with electronic Quality Management Systems (eQMS).
• Experience supporting and conducting internal, vendor, and client audits, with a working knowledge of audit lifecycles and reporting standards.
• Ability to assess quality risks, analyze root causes, and contribute to robust corrective and preventive actions.
• Good understanding of regulations and guidelines relevant to the conduct of clinical investigations, such as ICH GCP and EU Clinical Trial Regulation. Understanding of German and Italian local regulations a plus.
• Good understanding of the pharmaceutical industry and the clinical development process.
• General understanding of the computer systems validation process and regulatory requirements relevant to the use of electronic records and signatures, such as 21 CFR Part 11.
• General understanding of data protection laws and regulations, such as GDPR, CCPA, HIPAA and EU Directives.
• Awareness of ISO standards and requirements (e.g., 9001, 27001).
• Strong organizational skills and comfortable working in a fast-paced, dynamic environment with multiple priorities and stakeholders.
• Ability to simultaneously work with multiple complex projects and competing priorities.
• Ability to be careful, thorough, and detail oriented.
• Fluent in English, both written and verbal; fluency in Italian and/or French a plus.
• Clear and professional communication skills (written and verbal) to collaborate across global, cross-functional teams.
• High level of integrity, confidentiality, and accountability in handling sensitive and regulated data.
• Proficient with MS Office Suite, particularly Word, Excel, PowerPoint, and SharePoint/Teams.

• Ability to travel internationally.
• Current passport.
• Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.