Key Responsibilities

• Regulatory Tracking & Oversight:
  • Track and interpret international and regional regulations governing biospecimen procurement, biobanking, and cross-border transport of Human Biological Materials (HBM) (e.g., FDA, EMA, GDPR, HIPAA, ISO 20387).
  • Evaluate regulatory and ethical risks associated with incoming biospecimen cohorts and prospective sourcing projects.
• Vendor Compliance & Remote Monitoring:
  • Perform remote regulatory monitoring, desk audits, and compliance evaluations of external vendors, biobanks, and partner clinics.
  • Review and verify vendor accreditations, licenses, collection protocols, Informed Consent Forms (ICFs), and IRB/IEC approvals to ensure full ethical and legal compliance.
  • Establish and maintain vendor compliance checklists and tracking tools for onboarding and routine re-evaluations.
• SOP & Quality Documentation:
  • Author, review, and continuously update Standard Operating Procedures (SOPs) governing regulatory processes, vendor oversight, and biospecimen traceability.
  • Coordinate the electronic Quality Management System (eQMS / Cognidox) to ensure proper document control, review cycles, and regulatory compliance.
  • Ensure operational workflows strictly align with internal quality standards, customer requirements, and international regulations.
  • Support CAPA (Corrective and Preventive Action) tracking and resolution in cases of vendor compliance deviations.

Qualifications & Requirements

• Education & Experience:
  • Bachelor’s or Master’s degree in Life Sciences, Biotechnology, or a related field.
  • 5+ years of experience in Regulatory Affairs, Quality Assurance (QA), or Compliance within Biotech, Pharma, CRO, or Biobanking sectors.
• Core Competencies & Knowledge:
  • Strong understanding of international biospecimen regulations, ethical standards, GCP/GCLP, ISO 20387 (Biobanking), data privacy (GDPR/HIPAA), and IRB/IEC approval processes.
  • Practical experience in performing remote vendor compliance monitoring, desk audits, and reviewing ICFs/protocols (preferably).
  • Proven track record in drafting, reviewing, and implementing Standard Operating Procedures (SOPs) from scratch.
• Systems & Soft Skills:
  • Experience with electronic Quality Management Systems (eQMS). Hands-on experience with Cognidox is a strong plus (experience with similar systems is also acceptable).
  • High attention to detail, strong analytical skills, and ability to manage documentation workflows independently.
  • Languages: Fluent in English (written and spoken) with proficiency in medical, scientific, and regulatory terminology.

What We Offer

• 100% Remote Work: Fully remote working position, allowing you to work effectively from the comfort of your home office.
• Competitive Compensation: Attractive salary package corresponding to your experience, skills, and qualifications.
• Impactful Mission: Be a key contributor to global biotech, diagnostic, and drug discovery research by ensuring ethical and compliant sourcing of critical biospecimens.
• Professional Growth: Opportunities for professional development, training, and support in obtaining relevant industry certifications.
• Collaborative Environment: A dynamic, supportive, and international cross-functional team with open communication and direct workflows.

Find out more and apply