div>Reporting to the Associate Director, Quality Control Stability and Trending, the Manager, Quality Control Operations will be responsible for day-to-day oversight of routine batch testing at contract and internal Kiniksa testing laboratories.
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
As an independent Brand Representative, you will act as a key liaison between the brand and retail store environments, conducting recurring in-store visits to perform audits, ensure product quality, and elevate the brand experience. Through innovative in-store retail technology solutions, we bring products to life inside retail environments, helping brands optimize performance and grow in today's dynamic retail landscape.
p>The successful candidate will work cross‑functionally with Analytical Research & Development, Bioprocess Development, Manufacturing Technical Services, Manufacturing Operations, Regulatory Affairs, and Quality Assurance to drive the transfer, qualification, validation, and lifecycle management of analytical methods for gene‑edited cell therapy products and associated critical materials (e.g., mRNA). In addition, this position will contribute directly to regulatory filings, including specifications, analytical method validation reports, and CMC documentation, and will serve as a QC technical subject matter expert across program teams to ensure compliant, robust, and phase‑appropriate analytical strategies.
As a key contributor within the Technical Operations Team and player-coach, you will lead Quality Control activities supporting the development of our first clinical-stage autologous cell therapy program targeting solid tumors and drive a culture of rigorous thinking, exceptional collaboration and transparency, continuous learning, and outcomes focus. Develop and support a high performing team to execute department responsibilities; ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee engagement and development, and philosophically aligned rewards and recognitions practices.
Andover, Massachusetts30+ days ago
To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. This position is responsible for, but not limited to, the following:
- Overall management of quality control activities; oversee the development and implementation of robust systems and procedures to ensure evaluation, measurement and improvement of processes.