This organization focuses on gene therapy to treat immunological diseases (ex. Huntington Disease, Parkinson's Disease, Haemophilia) using AAV-based vectors. Having several products in the pipeline, they are all of them in different stages of development and clinical trials phases.
As a QA Associate Director you will lead the on-site QA staff to provide required oversite to GMP activities on site. You will represent Quality at the site management team and will be contact person for all external regulatory agency interaction in relation to GMP site activities.
- Manage a team of 5-6 Quality professionals either as individual contributors or people managers
- Support cGMP Manufacturing, Engineering, Validation, Supply Chain, and QC laboratory operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
- Responsible for tracking and trending QMS metrics including, but not limited to, those related to deviations, CAPA, Change Controls, OOS, and internal/external audits performance.
- Be main contact person for local and international Regulatory Agencies and manage these relationships effectively.
- Support the supplier quality program through review and approval of vendor change notifications, part number requests, raw material specifications, and raw material release, as necessary.
- Conduct/assist in internal audits against applicable quality system standards and regulations.
- Lead and host any regulatory agency or third-part inspections.
- Represent Quality Assurance on project teams and in meetings.
- Support the continuous improvement and oversight of Quality Management System procedures.
- Main Quality contact for site leadership team
- Mentor junior QA staff.
- Bachelor’s Degree and/or Master’s Degree in Life Sciences or Engineering
- 15+ years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
- People management skills (5+ FTE)
- Expertise in cGMP/ICH/FDA/EU regulations and guidelines
- Internal and/or external audit and Regulatory inspection experience
For more information please contact Carla Garcia at email@example.com or +31 (0) 20 658 98 01.