Supervisor/Sr Supervisor, Quality Assurance

About Us:

Eureka Therapeutics, Inc. is a privately held clinical-stage biotechnology company focused on developing novel T-cell therapies to treat cancers. Its core technology centers around its proprietary ARTEMIS® cell receptor platform and E-ALPHA® antibody discovery platform for the discovery and development of potentially safer and more effective T-cell therapies for the treatment of solid tumors and hematologic malignancies. The company currently has two clinical programs, ET140203 (ARYA-1 for adults and ARYA-2 for pediatrics) and ECT204 (ARYA-3), in Phase I/II US trials in patients with advanced liver cancer.

Eureka Therapeutics, Inc. is headquartered in the San Francisco Bay Area. For more information on Eureka, please visit www.eurekatherapeutics.com. ARTEMIS and E-ALPHA are registered trademarks owned by Eureka.

Job Description:

The Supervisor/Senior Supervisor, Quality Assurance is to work as part of the Quality Assurance group in the Clinical T-Cell Manufacturing (CTCM): Product Development Department. Responsibilities include supporting the establishment and development of quality systems for the manufacturing/quality control group as well as assisting in document control activities for Clinical Development group. The position will be based in either Emeryville, CA or Sacramento, CA (Emeryville, CA is preferred).

Responsibilities:

• Drives the implementation and administration of the eQMS software, ensuring seamless integration and user adoption.
• Manages the document control function, overseeing the entire document lifecycle to guarantee adherence to established procedures and regulatory compliance.
• Develops, reviews, approves, and implements critical quality documents, including standard operating procedures (SOPs), material specifications, forms, and templates, to support GMP manufacturing and quality control testing for Lentiviral Vector and T cell products.
• Reviews and approves quality control test method, test reports, certificates of testing, certificates of analysis, and technical protocols and reports, ensuring accuracy and compliance.
• Identifies and handles deviations and out-of-specification (OOS) results within CTCM. Initiates corrective and preventive action (CAPA) processes, investigates root causes, and ensures timely and effective CAPA closure. Ensures all deviations, OOS results, and CAPA records are accurate, complete, and auditable. Compiles and analyzes the deviation, OOS, and CAPA data for continuous quality improvement.
• Assists in development of training programs on quality systems, policies, procedures, and Good Practices (GxP) requirements for the CTCM team.
• Qualifies and approves new vendors providing products and/or services to support clinical trials, ensuring compliance with quality standards.
• Contributes to the optimization of quality systems through a phase-appropriate approach and collaborative effort, aligning with evolving regulatory requirements and industry best practices.
• Assists in internal and vendor audits and quality gap analyses to ensure compliance with regulatory guidelines.
• Assists with audits/inspections from regulatory agencies or third parties. Provides answers regarding the company’s quality systems and ensures the completion of corrective actions.
• Other duties as assigned

Minimum Qualifications:

• Bachelor’s degree in a scientific field required; an advanced degree is a plus.
• Minimum of 5 years of quality assurance experience in biotech/pharmaceutical industry.
• Solid knowledge in Good Manufacturing Practice (GMP) and ICH regulations, with the ability to correctly interpret and apply those standards pragmatically.
• Advanced Proficiency in Microsoft Word (formatting, templates, forms, embedded hyperlinks), with basic competence in Excel and Adobe Acrobat Professional.
• Hands-on experience administering eQMS and eLMS. Experience with DOT Compliance is preferred.
• Experience with quality systems (e.g., deviations, investigations, training and CAPA programs).
• Strong technical writing skills, with the ability to create clear, concise, and user-friendly documentation.
• Past QA experience in cell and gene therapy is a plus.
• Ability to work in a dynamic, science-driven biotech environment with limited resources.
• Ability to plan and execute multiple tasks simultaneously, as well as evaluate and resolve complex problems.

For the best fit, the candidate should be a fast learner who is detail-oriented, results-driven, and a team player with strong interpersonal skills capable of working collaboratively with colleagues. The candidate should be comfortable in a fast-paced environment, capable of adjusting workload based on changing priorities, and willing to take additional responsibilities outside of initial job description.

To Apply:

Please submit your resume or CV and cover letter to Jobscore. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.

Eureka Therapeutics is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, religion, color, sex, age, ancestry, national origin, marital status, veteran status, medical conditions, handicap, physical or mental disability, sexual orientation, or any other status protected by law.

If you are a recruiter or placement agency, please do not submit resumes to any employees at Eureka Therapeutics, Inc. prior to having a signed agreement. Eureka Therapeutics is not liable for and will not pay agency fees for candidates submitted by any agency other than its approved recruitment partners. Furthermore, any resumes sent to us without an agreement in place will be considered your company’s gift to Eureka Therapeutics and may be forwarded to our recruiters for their attention.