Associate Director QA (GLP/GCP) - ATMP environment

One of our most ground-breaking clients that specialize in gene therapy is looking for experienced Quality Assurance support in terms of non- and pre-clinical development. This is still a small but booming company so you can grow a lot with and within this company into your fullest potential while working in a great family atmosphere. My client supports personal training and development a lot in terms of education packages and they are flexible concerning working from home. In this job you can maintain a great work-life balance while bringing value to a company that changes people's lives.

Responsibilities:

• Lead internal teams consultants and external vendors in terms of quality and compliance.
• Provide R&D Quality Assurance to support bioanalytical assay development, execution, and transfer.
• Provide QA oversight of both the internal and contract laboratories to support GLP and GCP studies.
• Identify, prioritize, and remediate compliance gaps and risks cross-functionally.
• Develop and implement risk-based audit and oversight strategies for GLP and GCP laboratory vendors and internal processes.
• Manage routine audits and lead high-complexity and high-risk audits
• Lead cross-functional investigations, root cause analysis, and CAPA development for significant departures from GLP at vendors
• Develop and implement inspection readiness plans

• Approximately 20% domestic and international travel required.

Requirements:

• Degree in a health related field (biology, pharma, chemistry,…) with at least in 8 years of experience in the (bio)pharmaceutical industry.
• Minimum 4 years of expertise in application of global GLP standards.
• Expertise in global GCP standards is a plus

Benefits:

• Attractive salary package
• Yearly education package to develop yourself
• Homeworking up to 2-3 days a week
• Easy reachable offices
• A chance to gain experience in a very interesting and innovative ATMP environment

If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!