What are the responsibilities and job description for the Director of Quality Assurance position at BioSearch Consultancy?
BioSearch has partnered with a cutting-edge, clinical-stage biotech company revolutionizing patient in the T cell space. We are seeking an accomplished Director of Quality to lead Quality Assurance efforts for both in-house and virtual GMP operations, driving the development of transformative T cell therapy products.
This role is instrumental in supporting IND submissions, overseeing clinical manufacturing, and building a compliant, scalable Quality Management System (QMS) to align with the company’s ambitious growth plans.
Responsibilities:
- Build and lead a high-performing Quality Assurance team, fostering growth and best-in-class performance.
- Develop and enhance a robust QMS to ensure compliance with regulatory standards and future commercial readiness.
- Oversee Quality Operations, including lot disposition, audits, training, and document management.
- Serve as a strategic leader, collaborating across departments to support GxP operations and clinical programs.
- Drive inspection readiness, manage regulatory inspections, and champion continuous improvement initiatives.
Experience:
- 15 years of Quality Assurance experience, with expertise in cGMPs, ICH guidelines, and regulatory compliance for advanced therapeutics.
- Proven leadership in cell and gene therapy, orphan drugs, or novel dosage forms.
- Exceptional problem-solving, critical thinking, and communication skills.
- Experience with regulatory filings, team development, and strategic planning in fast-paced environments.
- Advanced degree in biological sciences, biochemistry, or related fields preferred.
- Join a mission-driven organization poised to redefine the future of cell therapy. Ready to lead the charge in quality excellence?