About Kamau Therapeutics, Inc.

Kamau Therapeutics is a clinical-stage biotech founded by a deeply collaborative team of hematologist-oncologists and engineers. We are pioneering a precision homology-directed repair (HDR) gene editing platform to create definitive autologous hematopoietic stem cell (HSC) therapies. Our mission begins with our lead program: a first- and best-in-class curative treatment for sickle cell disease (SCD). This program now serves as our powerful proof point, establishing a core competence in site-specific genome editing of HSCs. We are next leveraging this mastery to engineer myeloid and lymphoid lineages, fueling a growing pipeline of next-generation therapies for cancer immunotherapy, autoimmune disease, and neurodegeneration. We operate with a high-impact, collaborative spirit, focused on redefining the speed and reach of therapeutic development.

Role Summary

Kamau Therapeutics is seeking an experienced Senior QA Manager / QA Manager to join our growing Quality Assurance function as a key hands-on contributor. The successful candidate will strengthen and expand core quality systems across investigations, CAPA, change control, supplier quality, lot release, and material review board (MRB) activities within a cell therapy manufacturing environment, and will serve as a trusted on-site quality presence at CDMO and supplier locations. This role drives compliant, timely, and risk-based decision-making while partnering closely with Manufacturing, Regulatory Affairs, Supply Chain, and Technical Operations. A key part of this role is working collaboratively with CDMO (Contract Development and Manufacturing Organization) QA counterparts and other external partners to ensure aligned, compliant, and efficient quality oversight of outsourced activities. The ideal candidate combines an agile mindset, awareness of phase-appropriate decision making, and strong technical and quality systems expertise with the ability to influence cross-functional and cross-organizational stakeholders, coach and mentor junior colleagues, and drive continuous process improvement in a regulated (GMP) environment.

This is a ‘roll-up-your-sleeves’ role for a builder who thrives in a fast-paced, unstructured, and highly collaborative startup environment. The ideal candidate approaches work with curiosity, humility, and a growth mindset, taking initiative and contributing across functions and levels. At Kamau, we’re building a mission-driven culture where scientific rigor, creativity, and collaboration power both personal and company growth.

Key Responsibilities

• Lead and/or oversee investigations into deviations, OOS/OOT results, complaints, and non-conformances, driving root cause analysis with structured problem-solving tools (5-Why, Fishbone, FMEA, Is/Is Not) and ensuring timely closure per site and regulatory timelines.
• Own the CAPA program: effectiveness checks, trending, aging metrics, and escalation of systemic issues to management, and coach investigators and cross-functional teams on investigation quality, documentation, and root cause rigor.
• Manage the change control process for facility, equipment, process, and documentation changes; assess change impact (regulatory, validation, supply, quality), ensure appropriate risk assessments are completed, and partner with RA, Manufacturing, and Engineering to ensure changes are implemented compliantly and on schedule.
• Own supplier qualification, requalification, and performance monitoring programs; lead or support supplier audits and manage supplier corrective action requests (SCARs); evaluate incoming material non-conformances and drive resolution with suppliers; and maintain the approved supplier list and quality agreements.
• Provide floor coverage across the full manufacturing sequence, from cell selection and cryopreservation through gene correction, culture, and final harvest and formulation. Verify critical process parameters and reagent formulations at the bench during execution and escalate departures from the batch record in real time. Serve as Kamau’s embedded QA presence at our CDMO, working as the quality counterpart to our MSAT.
• Provide on-site quality oversight at CDMO and supplier sites, including real-time review of batch execution, deviations, and manufacturing records during production campaigns, and escalate quality risks promptly.
• Review and approve executed batch records, testing data, and associated quality records to support lot disposition; ensure release decisions are supported by complete, compliant documentation and appropriate risk assessment; partner with QC and Manufacturing to resolve documentation gaps prior to release; and support release of raw materials, in-process, and finished product as applicable.
• Actively participate in MRB to disposition non-conforming materials and finished goods, ensure disposition decisions are documented and risk-justified, and track MRB trends to identify recurring quality issues.
• Review and approve qualification, validation, and change documentation (protocols, reports, and specifications) to ensure process and method readiness is documented to GMP standards.
• Support the transition of drug substances and materials from Research Use Only (RUO) status to GMP-compliant manufacturing, including gap assessments against applicable cGMP requirements, readiness plans with Process Development, Manufacturing, and RA (specifications, testing strategy, documentation, and supplier and material qualification), and appropriate change control, risk assessment, and quality oversight.
• Contribute to authoring or reviewing quality documentation (SOPs, specifications, protocols) needed to support the GMP transition and inspection readiness.
• Support regulatory submissions, responses to health authority findings, and inspection readiness activities; ensure quality systems and documentation remain audit- and inspection-ready (FDA, EMA, ISO, etc.); and partner with RA on product registrations, labeling changes, and post-approval change assessments as needed.
• Serve as a key QA liaison with CDMO Quality counterparts, ensuring alignment on quality standards, timelines, and issue resolution, and partner with CDMO QA on investigation, CAPA, change control, and lot disposition activities for outsourced manufacturing, ensuring consistency with internal quality systems and regulatory expectations.
• Facilitate regular quality review meetings and governance calls with CDMO partners to track open items, metrics, and escalations, and support technical transfer and onboarding of new CDMO and supplier relationships from a quality systems perspective.
• Collaborate cross-functionally with Manufacturing, Supply Chain, Regulatory Affairs, Technical Operations, and R&D to ensure seamless communication and issue resolution across internal and external sites and maintain compliance with quality standards and company SOPs.
• Identify opportunities to streamline and standardize quality processes (investigations, CAPA, change control, lot release, MRB) to improve cycle time, right-first-time rates, and overall efficiency; lead or support process improvement initiatives and eQMS enhancements using structured methodologies (Lean, Six Sigma, DMAIC); and benchmark internal and CDMO quality processes against industry best practices.
• Present quality metrics (investigation aging, CAPA effectiveness, supplier performance, right-first-time) to leadership, represent QA during internal and external audits and inspections, and champion a culture of continuous improvement and quality excellence across internal and external partner teams.
• Coach and mentor junior quality team members and cross-functional colleagues as the Quality function grows, and contribute to templates, standard work, and lessons learned.

Required Qualifications

• Bachelor’s degree in a scientific, engineering, or related technical discipline (Life Sciences, Chemistry, Engineering, or similar); advanced degree a plus.
• 8+ years of progressive Quality Assurance experience in a regulated industry (pharmaceutical, biotech, medical device, or combination products), including 5+ years working in a cell therapy environment.
• Direct experience in a cell therapy manufacturing environment, including autologous and/or allogeneic manufacturing processes, short shelf-life and expedited release logistics, chain of custody and chain of identity (CoC/CoI), and cryopreservation-related quality considerations.
• Demonstrated hands-on experience across quality investigations, CAPA, change control, supplier quality, lot release and batch disposition, and MRB.
• Experience working with CDMOs or other outsourced manufacturing and testing partners, including on-site quality oversight.
• Direct experience supporting regulatory submissions or interfacing with Regulatory Affairs.
• Demonstrated track record of leading or contributing to process improvement initiatives within a quality organization.
• Experience coaching or mentoring junior quality staff.
• Strong working knowledge of cGMP, FDA 21 CFR Parts 210/211/820 (as applicable), ICH guidelines, and ISO 9001/13485 (as applicable); familiarity with FDA guidance on cell and gene therapy products (e.g., 21 CFR Part 1271, relevant CBER guidance) a plus.
• Demonstrated root cause analysis and risk assessment expertise (FMEA, RCA tools).
• Experience with electronic Quality Management Systems (eQMS) such as TrackWise, MasterControl, Veeva QMS, or equivalent.
• Working knowledge of data integrity expectations (ALCOA+, 21 CFR Part 11).
• Strong written and verbal communication skills; ability to influence without direct authority.
• Proven ability to manage multiple priorities and drive closure on complex, cross-functional quality issues.
• Experience hosting or supporting regulatory inspections and customer and supplier audits.
• Data-driven mindset with experience presenting quality metrics and trends to leadership.
• Ability to work onsite and in gowned manufacturing areas and willingness to travel to CDMO and supplier sites, estimated 30–50%.

Preferred Qualifications

• Prior experience in biologics or advanced therapy medicinal products (ATMP) manufacturing, including gene-edited or hematopoietic stem cell products.
• Familiarity with specialized cell therapy quality considerations: donor eligibility/screening, apheresis material handling, viral vector quality, potency assay oversight, and cold chain/cryogenic logistics.
• Experience supporting the transition of materials or processes from Research Use Only (RUO)/non-GMP state to GMP-compliant manufacturing.
• Prior experience as a QA Person-in-Plant or embedded quality lead in a cross-functional, matrixed team.
• Experience in a multi-site or global quality organization.
• Familiarity with combination products, biologics, or sterile manufacturing.

The Right Candidate Will

• Be a high-agency, ‘do-what-it-takes’ contributor. You don’t wait for instructions; you identify the critical path, flag risks, and build solutions.
• Be relentlessly output-focused. You are driven by delivering a robust, scalable process, not by ‘doing tasks or process’ for its own sake.
• Be a fluid and pragmatic collaborator. You understand that in a small company, titles are secondary to the mission. You are eager to contribute across functions and levels.

Compensation

The expected base salary range for this position is $145,000–$195,000 per year.

Actual compensation will depend on qualifications, experience, and internal equity. This position is also eligible for an annual target bonus and equity in the form of stock options.

In addition to base salary and equity, we offer a comprehensive Total Rewards program including health, dental, and vision coverage, retirement benefits, and paid time off.

Work Requirements

The role is based in South San Francisco and/or Redwood Shores, CA. It requires five days per week onsite and involves periodic travel within the US to CDMOs to support project demands. This role is performed in an office environment, with on-site presence at CDMO and supplier manufacturing facilities as appropriate. It requires the ability to gown and work in controlled environments with required personal protective equipment, travel frequently, sit or stand for extended periods, and occasionally lift up to 25 pounds.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions of the role.

Equal Employment Opportunity

Kamau Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by applicable law, and we are committed to providing reasonable accommodations to applicants and employees with disabilities.

Additional Information

Employment is contingent on a background check conducted only after a conditional offer. Consistent with the California Fair Chance Act, we consider qualified applicants with criminal histories and conduct an individualized assessment of any conviction history. Kamau Therapeutics participates in E-Verify. See our Applicant Privacy Notice.

Disclaimer

This job description is intended to describe the general nature and level of work performed and is not an exhaustive list of all responsibilities, duties, or qualifications associated with the role.

Recruiter Policy

Kamau does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, Kamau will not consider or agree to payment of any referral compensation or recruiter fee.

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