Build the quality management system and QA team, while assuring quality across outsourced GMP manufacturing, preclinical studies and clinical trials.
The role
As QA Manager, you will build the quality management system and QA team needed to take a first product into clinical development. You will develop the quality strategy and implement it across the organization. You will ensure quality and compliance for outsourced GMP manufacturing, preclinical toxicology studies and clinical trials.
Responsibilities
- Develop and implement QA policies and procedures.
- Ensure compliance with applicable regulatory standards and guidelines, including GMP, GLP and GCP.
- Lead QA activities related to GMP, GLP and GCP.
- Develop and implement risk management strategies; manage quality issues, CAPA and risk assessments.
- Oversee and conduct internal, external and vendor audits.
- Work with CMC, R&D and clinical teams to maintain quality throughout all development phases.
- Prepare for and lead regulatory inspections.
- Keep up to date with industry developments and regulatory changes.
- Guide and train quality and cross-functional teams on quality principles, compliance requirements and good practices in cell and gene therapy.
Requirements
- Bachelor's or master's degree in a relevant scientific discipline.
- At least 10 years of QA experience in the pharmaceutical or biotechnology industry.
- Gene therapy experience is an advantage.
- Strong knowledge of GMP, GLP, GCP and regulatory requirements.
- Proven QA experience in preclinical and clinical phases.
- Leadership and management skills, with the ability to lead cross-functional teams and collaborate with stakeholders.
- Excellent communication and organizational skills.
Practical information
- Location: Amsterdam, Noord-Holland.
- Work schedule, hours, contract and salary are not specified.