Compliance & Quality Assurance Consultant (Pharmaceuticals)

Location: Sweden. Supports remote working, but hybrid basis is encouraged for those within commuting distance of an office.

Company

hirify.global provides expert consulting services in regulatory sciences, quality, and compliance to biotech, med device, and pharmaceutical organizations.

What you will do

• Manage compliance and QA projects, including QMS development, QA oversight, and regulatory agency action responses.
• Conduct GxP auditing and lead audit preparation and reporting.
• Provide consultation on GxP issues, deviations, and the implementation of appropriate CAPA.
• Develop and maintain quality systems through SOP writing and training.
• Participate in the sales process to identify project scope and effort required for client needs.
• Promote CQA services through the creation of social media content and blogs.

Requirements

• Must be based in Sweden.
• Minimum 5 years of relevant experience in quality assurance and regulatory/GxP compliance.
• Bachelor's degree in a scientific discipline (MSc or PhD preferred).
• Strong working knowledge of GxP principles, including CFRs and EU GMP/GDP regulations.
• For auditing roles: minimum 1 year of experience leading audits and at least 5 audits performed in the past year.
• Proficiency in English (written and oral); proficiency in another European language is preferred.

Nice to have

• Eligibility or registration as a Qualified Person (QP), Responsible Person (RP), or Responsible Person import (RPi).

Culture & Benefits

• Inclusive workplace committed to diversity, equity, and inclusion.
• Flexible work arrangement supporting both remote and hybrid collaboration.
• Collaborative and entrepreneurial environment.
• Personalized application review process without the use of AI screening tools.