Business Director at MOI Global driving B2B marketing strategies in Australia. Responsible for leadership and execution of marketing initiatives to align with business growth.
About the role
- Leading Quality Control operations for biopharmaceutical company Kyverna Therapeutics. Overseeing compliance and strategic leadership in cell therapy development and commercialization.
Responsibilities
- Provides enterprise-level strategic and operational leadership for Quality Control activities supporting both development and commercial programs.
- Serves as the primary point of accountability for QC oversight across the organization, including outsourced testing networks, stability programs, regulatory submissions, and global inspection readiness.
- Partners closely with Technical Development, Quality Assurance, Regulatory Affairs, and other cross-functional stakeholders to ensure compliance with global regulatory requirements while enabling efficient pipeline advancement and commercial execution.
- Responsible for building and sustaining a scalable, inspection-ready QC organization.
- Drives continuous improvement across the quality system, provides strategic input into program and manufacturing decisions, and represents QC to the executive level.
- Has significant influence on regulatory outcomes, operational performance, and the overall credibility of the company’s quality function.
Requirements
- A minimum of 10 years of progressive Quality Control experience in a biotechnology or pharmaceutical environment is required.
- A Bachelor’s degree in a scientific discipline is required; a Master’s degree or advanced scientific degree is preferred.
- Demonstrated experience supporting cellular therapy and or autoimmune disease programs is required.
- Direct, hands-on involvement in IND and BLA submissions, stability program design and execution, and regulatory inspections is required.
- Strong working knowledge of global GMP regulations, outsourced laboratory oversight models, and integrated quality systems is required.
- Proven ability to lead in a matrixed, fast-paced environment, balancing strategic leadership with operational execution.
- Exceptional verbal, written, and interpersonal communication skills, with the ability to clearly convey complex scientific and regulatory information to diverse audiences.
- Demonstrated ability to independently manage multiple priorities with sound judgment, limited oversight, and a high degree of accountability.
- A collaborative leadership style with a strong track record of partnering effectively across Technical Operations, Quality, Regulatory Affairs, and other cross-functional teams.
Benefits
- Annual bonus
- Comprehensive benefits
- Participation in the Company’s stock option plan
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