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Associate Director Quality
2 months ago
Adaptimmune is a leading cell therapy company that requires a highly skilled Associate Director Quality to lead our quality assurance team. As a key member of our organization, you will be responsible for ensuring the quality of our products and processes, ensuring compliance with regulatory requirements, and driving continuous improvement.
Key Responsibilities:- Quality System Leadership: Develop and implement quality systems that meet regulatory requirements, ensuring a culture of quality and compliance throughout the organization.
- Lot Release Management: Oversee the lot release process, ensuring that all quality events, change controls, CAPAs, and other required documentation are completed and closed prior to material/lot release.
- Quality Assurance: Manage the quality assurance department, ensuring that all quality-related activities are performed in accordance with regulatory requirements and company policies.
- Regulatory Compliance: Ensure that all quality-related activities are compliant with relevant regulatory requirements, including GMP, ISO, and other applicable standards.
- Process Verification: Participate in process verification and technical transfer projects, ensuring that all quality-related activities are performed in accordance with regulatory requirements and company policies.
- Quality Training: Develop and deliver quality training programs to ensure that all employees understand their quality responsibilities and are equipped to perform their jobs in a quality manner.
- Education: Degree in a scientific discipline.
- Experience: Hands-on experience in pharmaceutical industry within quality roles.
- Skills: Excellent technical writing skills, knowledge of regulatory compliance for biologics manufacture, lot release, and quality systems.
Adaptimmune is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to creating a diverse and inclusive work environment that values and respects the contributions of all employees.
