Director developing and marketing differentiated investment insights for Columbia Threadneedle Investments. Collaborating across teams to produce actionable thought leadership for clients in North America.
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
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Director for Commercial Frontline leading commercial integration of strategies at Coca - Cola. Collaborating with Franchise and Bottling system to drive business growth in Africa.
Director, Real Estate Services leading workplace strategy and capacity management for Mastercard's global portfolio. Responsible for stakeholder engagement and operational efficiency across office spaces.
Product Development Director bringing IT - driven product enhancements to market for P&C insurance at USAA. Collaborating across functions to ensure compliance and improve product offerings.
Executive Director leading immunology and cardiovascular research at Bristol Myers Squibb. Driving early discovery portfolio and strategic collaborations in drug discovery.
Director of Dealer Relations leading account management and sales efforts in the automotive industry. Focus on client expansion, team development, and cross - functional collaboration for maximum success.
Underwriter providing insurance and surety solutions for the Construction Services team. Managing complex risk, profitability, and relationships with clients and agents.
Director of Telehealth responsible for planning and managing telehealth programs in a home health organization. Collaborating with teams to improve patient outcomes and access to care.
Director of Health Economics and Outcomes Research leading HEOR strategy for a medical technology company. Driving clinical and health economic messaging through market access strategy and evidence generation.
Leading device development for prefilled syringes and auto - injectors at Oruka Therapeutics. Seeking experienced professionals to drive end - to - end development from clinical stages through commercialization.