Senior Manager of CMC Quality Assurance - Kamautx.com

We are seeking an experienced Senior Manager of CMC Quality Assurance to spearhead the quality assurance initiatives for our pioneering curative stem-cell therapies. This role involves establishing and refining the quality assurance processes for the development of HSPC based, HDR (homology directed repair) therapies.

What You Will Do:

• Lead cGMP quality assurance activities for all relevant manufacturing operations, including product disposition via batch record and certificate of analysis (COA) review, in collaboration with our Contract Manufacturing Organization (CMO).
• Develop, implement and manage a comprehensive electronic Quality Management System (eQMS) to support pre-clinical and clinical manufacturing and clinical operations, including development, review and approval of internal documentation, such as Standard Operating Procedures (SOPs) and methods.
• Support development and implementation of Clinical Affairs SOPs
• Responsible for core eQMS processes such as CAPAs, change controls, deviations, CAPAs and Training documentation.
• Evaluate quality events, incidents, queries and complaints to support CMC and clinical affairs
• Perform Quality Management Review by providing periodic reports, conducting management review meetings and recommending improvements to the quality system.
• Coordinate and conduct audits to qualify vendors/suppliers and CMO, and create quality agreements on an as needed basis.
• Support IND submissions and regulatory interactions
• Document internal regulatory processes

Requirements

• Bachelor’s degree or higher in Life Sciences or a related field.
• At least 5+ years of experience in GXP and Quality Systems within the biotechnology sector, focusing on GMP biopharmaceutical manufacturing with a preference for cell and gene therapy products.
• Profound knowledge of phase-appropriate cGMP regulations, including FDA, EMA, ISO standards, and ICH guidelines, especially as they relate to clinical programs.
• Proven track record in regulatory compliance, including submission reviews and hosting regulatory inspections.

What We Value:

• Comprehensive understanding of GMPs, CMC requirements, and a strong background in Quality and Compliance.
• Familiarity with ICH guidelines, and regulatory requirements from FDA/EMA, including health authority inspection protocols.
• Demonstrated ability to lead thoughtfully in CMC Quality Assurance.
• Effective collaboration and strong interpersonal skills.
• Excellent communication skills, both verbal and written.
• Capable of working in a dynamic, fast-paced environment and solving complex problems with a keen attention to detail.

Benefits

Compensation

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers.

A Summary of Benefits is available for all applicants.

The base pay range for this position is expected to be $125,000 - $165,000 annually, however, the base pay offered

may vary depending on the market, job-related knowledge, skills and capabilities, and experience.

EEO Statement

Kamau Therapeutics is an equal-opportunity employer. We believe that our strength is in our

differences. Our goal to build a diverse and inclusive team began on day one,

and it will never end.