Senior QA Consultant
Location: Leiden Area, The Netherlands
Contract Duration: 6–12 months (extension possible)
Start Date: ASAP
About the Role:
We are seeking an experienced Senior Quality Assurance Consultant to provide freelance support within a leading Biotech organization. The consultant will play a key role in strengthening our supplier management and audit readiness processes, ensuring full compliance with GMP and global regulatory expectations.
Key Responsibilities:
- Lead and coordinate external GMP audits, including preparation, hosting, and follow-up of audit actions.
- Manage the supplier qualification process for critical material and service providers, including initial assessments, risk evaluations, and periodic requalification.
- Evaluate supplier quality systems and ensure compliance with internal and external standards.
- Support Quality Agreements, technical documentation reviews, and supplier performance monitoring.
- Provide QA oversight for outsourced activities and ensure alignment between internal quality systems and external partners.
- Contribute to continuous improvement of the supplier management and audit framework.
Requirements:
- Minimum 8+ years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- Proven track record in managing external GMP audits (as lead auditor or auditee).
- Strong experience with supplier qualification and management.
- Solid understanding of EU GMP, ICH Q10, and related regulatory frameworks.
- Excellent communication and stakeholder management skills.
- Fluent in English, Dutch Highly appreciated.
Preferred:
- Previous experience working with CDMOs, CMOs, or external testing laboratories.
- Certification as a GMP Lead Auditor is a plus.
Interested? Reach out directly at t.sylla@panda-int.com