GCP Compliance & QA Consultant (Medtech)

TL;DR

GCP Compliance & QA Consultant (Medtech): Providing expert regulatory and quality assurance consulting for biotech and pharmaceutical clients with an accent on GxP compliance, auditing, and risk management. Focus on implementing CAPA systems, ensuring adherence to FDA/EMA/ICH regulations, and supporting clients through the full product lifecycle.

Location: Must be based in the United States. Hybrid work is encouraged for those within commuting distance of an office.

Company

hirify.global is a global consulting firm providing end-to-end solutions for biotech, med device, and pharmaceutical organizations to accelerate scientific breakthroughs.

What you will do

• Represent the company in quality assurance and regulatory GxP matters.
• Provide expert consultation and project management within the CQA business practice.
• Execute risk-based and phase-appropriate GxP projects for clients.
• Support the sales process by identifying scope and effort for client needs.
• Develop social media content and blogs to promote CQA services.
• Provide support for deviations, non-conformances, and CAPA implementation.

Requirements

• Minimum 5 years of relevant experience in quality assurance and regulatory GxP compliance.
• Bachelor’s degree in a scientific discipline required.
• Strong working knowledge of GxP principles, CFRs, and EU GMP/GDP regulations.
• Recent auditing experience (at least 5 audits performed in the past year).
• Ability to travel as required for client projects.
• Professional proficiency in English required.

Nice to have

• Graduate degree (MSc or PhD) in a scientific discipline.
• Experience as a Qualified Person (QP), Responsible Person (RP), or Responsible Person import (RPi).

Culture & Benefits

• Commitment to diversity, equity, and inclusion.
• Supportive environment for innovative and entrepreneurial spirits.
• Personalized review of all applications by the recruitment team.
• Emphasis on work-life balance and professional development.