At KSQ Therapeutics, we seek to understand the role of every human gene in each disease, each tissue, and each cell that we study. This comprehensive approach has resulted in a massive, experimentally derived dataset that we have found to be remarkably predictive of past successes and failures in oncology and immuno-oncology product development. Utilizing this approach, we also identified a number of opportunities for the development of new medicines. As a result, we have aggressively invested in these distinct, highly validated pathways for new drug development with the expectation that the medicines we create may become the next breakthrough products for patients.
Founded in late 2015, KSQ is a clinical-stage biotech that has rapidly advanced the field of CRISPR-enabled functional genomics, from in vitro cell autonomous screens to more complex genome-scale screens of immune cells in vivo. The company has expanded the scope of its technology to include multiple cell types and to unlock areas beyond oncology. KSQ is led by a team of accomplished industry experts in drug discovery and development.
The QA Associate will support quality operations activities for the manufacture of cellular therapy products. This highly dynamic role will contribute to the advancement of KSQ products by ensuring quality oversight at contract manufacturing facilities and contributing to the Culture of Quality by facilitating the evolvement of the internal Quality Management System.
- Ensure the safety and quality of manufactured product through the review and approval of executed batch records
- Provide quality oversight of external quality records including: deviations, change controls, investigations…etc)
- Interface with external vendors to provide risk-based phase appropriate oversight
- Support the Vendor management program including: audits, development and application of vendor scorecards, and assessment of external change notifications
- Review and approve internal quality system records including: deviations, CAPAs, and change controls
- Support administration of the internal electronic Quality Management System
- Administer and evolve the training program to ensure a state of GxP compliance
- Generate and gather metrics to support the development of internal Quality Management Review
WHAT YOU’LL BRING TO THIS ROLE
- BS/BA in a science/engineering field and a minimum of 3+ years working in Quality, with experience in cell therapy (or applicable) environment preferred.
- Demonstrated ability to interact with cross-functional to drive a Quality Culture and continuous improvement
- Experience with Quality oversight of external vendors
- Excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines
- Experience in maintaining, and optimizing a Quality Management System
- Specific skills include, but are not limited to Deviation/CAPA Management, Change Control, Vendor Management
KSQ is deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
KSQ is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
KSQ Therapeutics is proud to be an Equal Opportunity Employer.
COVID-19 vaccination is a condition of employment at KSQ, subject to reasonable accommodation where required by law. Employees must be fully vaccinated by date of hire to be considered.
