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Manager, Global Quality Assurance

1 mese fa

Verona, Italia Alira Health A tempo pieno

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 Manager, Global Quality Assurance works closely with the QA team and practice area leaders in the implementation of the quality management system (QMS), ensuring regulatory compliance and audit readiness. This leadership role will help oversee and streamline QA activities across the organization, driving quality initiatives, managing complex audits, and supporting strategic goals.


Job Description


ROLE

The Manager, Global Quality Assurance works closely with the QA team and practice area leaders in the implementation of the quality management system (QMS), ensuring regulatory compliance and audit readiness.


KEY RESPONSABILITIES
Tactical
  1. Collaborates with practice area leaders in the development, implementation and maintenance of standard operating procedures, instructions and other QMS documentation.
  2. Leads teams in the preparation for, hosting, and response to Sponsor and ISO surveillance audits and regulatory inspections.
  3. Leads teams or participates in the documentation, investigation, resolution and closure of quality issues (such as deviations, CAPAs, and GCP and data breaches), audit findings, and customer complaints.
  4. Leads teams towards timely completion and closure of client audit response commitments.
  5. Performs periodic internal and vendor audits.
  6. Prepares internal documents and reports required by Alira Health procedures.
  7. Manages the creation and maintenance of client and audit data rooms.

Operational
  1. Collaborates in the implementation of the global Quality Policy and QMS.
  2. Provides interpretation of QMS and regulatory requirements to practice area leads, offering risk-based, compliant, and creative solutions to complex problems.
  3. Collects, aggregates, and/or reports quality metrics data that inform quality management reviews of the QMS.
  4. Supports the implementation of risk mitigation strategies based on quality management review outcomes.
  5. Participates in activities related to global facilities maintenance and business continuity.
  6. Participates in or leads internal and project meetings as required.

Strategic
  1. Maintains clear and regular communication with QA and other staff.
  2. Responds to inquiries from staff efficiently and effectively.
  3. Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, ISO standards and company SOPs.
  4. Escalates issues appropriately, providing alternative, compliant options.
  5. Performs additional duties as assigned.

DESIRED QUALIFICATION & EXPERIENCE
  1. BS/BA from an undergraduate program or equivalent experience.
  2. A minimum of 5 years of experience in a QA role, including a minimum of 3 years of experience in document and training management, and the conduct of internal and external audits.
  3. Good understanding of regulations and guidelines relevant to the conduct of clinical investigations, such as ICH GCP.
  4. Good understanding of the pharmaceutical industry and the clinical development process.
  5. General understanding of the Alira Health organization and its various business units.
  6. 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.
  7. General understanding of ISO standards and requirements.
  8. General understanding of data protection laws and regulations, such as GDPR, CCPA, HIPAA and EU Directives.
  9. Careful, thorough, and detail oriented.
  10. Ability to multi-task and work effectively in a fast-paced environment.
  11. Fluent in English, both written and verbal; fluency in Italian and/or French a plus.
  12. Good communication and interpersonal skills.
  13. Proficient with MS Office Suite, particularly Word, Excel, PowerPoint, and SharePoint/Teams.

Languages

English


Education

Bachelor of Arts (BA), Bachelor of Science (BS)


Contract Type

Regular

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