Manager, Global Quality Assurance

4 settimane fa

verona, Italia Alira Health Group A tempo pieno

Manager, Global Quality Assurance page is loaded

Manager, Global Quality Assurance

Apply remote type Hybrid locations Verona Bologna-Remote Barcelona-Remote Padova-Remote Verona-Remote time type Full time posted on Posted Yesterday job requisition id JR000288

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.

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

  • Collaborates with practice area leaders in the development, implementation and maintenance of standard operating procedures, instructions and other QMS documentation.
  • Leads teams in the preparation for, hosting, and response to Sponsor and ISO surveillance audits and regulatory inspections.
  • 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.
  • Leads teams towards timely completion and closure of client audit response commitments.
  • Performs periodic internal and vendor audits.
  • Prepares internal documents and reports required by Alira Health procedures.
  • Manages the creation and maintenance of client and audit data rooms.

Operational

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

Strategic

  • Maintains clear and regular communication with QA and other staff.
  • Responds to inquiries from staff efficiently and effectively.
  • Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, ISO standards and company SOPs.
  • Escalates issues appropriately, providing alternative, compliant options.
  • Performs additional duties as assigned.
DESIRED QUALIFICATION & EXPERIENCE
  • BS/BA from an undergraduate program or equivalent experience.
  • 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.
  • Good understanding of regulations and guidelines relevant to the conduct of clinical investigations, such as ICH GCP.
  • Good understanding of the pharmaceutical industry and the clinical development process.
  • General understanding of the Alira Health organization and its various business units.
  • 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 ISO standards and requirements.
  • General understanding of data protection laws and regulations, such as GDPR, CCPA, HIPAA and EU Directives.
  • Careful, thorough, and detail oriented.
  • Ability to multi-task and work effectively in a fast-paced environment.
  • Fluent in English, both written and verbal; fluency in Italian and/or French a plus.
  • Good communication and interpersonal skills.
  • 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

About Us

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle.

Why Work at Alira Health?

With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork.

Join Our Team

We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.

Introduce yourself to our Recruiters Apply to one of our open jobs or send us your spontaneous application.

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