We are looking for a Quality Assurance Manager who will play a critical role in ensuring the accuracy, compliance, and security of our regulatory information and document management solutions. If you are passionate about QA, information security, and global compliance frameworks, we’d love to connect with you!
What You’ll Do
- Lead QA of eCTD authoring tools, ensuring compliance with ISO 9001 & ISO 27001.
- Ensure regulatory compliance with GDPR & FDA CFR Title 21 Part 11 for secure document handling.
- Develop QA strategies, validation methods, and testing protocols aligned with FDA & EMA standards.
- Monitor system performance, troubleshoot issues, and drive continuous improvements.
- Conduct audits and validation tests to safeguard data integrity & cybersecurity.
- Train stakeholders and foster a culture of compliance and knowledge-sharing.
- Collaborate with IT teams/vendors to implement enhancements and resolve technical challenges.
- Stay updated on regulatory tech advancements, cybersecurity, and compliance frameworks.
- Participate in client audits and support organizational-level compliance training.
What We’re Looking For
- Bachelor’s/Master’s in Regulatory Affairs, Life Sciences, Computer Science, or related field.
- 5-8 years of experience in regulatory submissions, eCTD tools, QA, and data security compliance.
- Strong expertise in ISO standards, FDA, EMA, ICH guidelines, and GDPR.
- Hands-on experience with process validation, security testing, and compliance assessment.
- Proven ability to lead cross-functional teams and manage regulatory IT systems.
- Familiarity with automation tools for submission workflows.
- Certifications in Regulatory Affairs, Quality Management (ISO 9001), or Information Security (ISO 27001) preferred.