Director/Associate Director of Quality
Clinical Development | Emeryville, CA | Full Time
Eureka Therapeutics is a privately-held biotechnology company focused on developing novel T cell-based immunotherapies for hematological malignancies and solid tumors. Our unique platform is aimed at developing safe and effective genetically engineered T cells against surface cancer antigens as well as TCR-mimic antibodies, which recognize previously inaccessible cancer antigens specific for solid tumors. We have built a strong pipeline of innovative drugs, with the most advanced candidates in clinical stage. In addition to our internal drug discovery programs, Eureka has ongoing partnerships with several major pharma and academic centers of excellence. To learn more about us, please visit our website at www.eurekatherapeutics.com.
The Director of Quality is responsible to build and lead the Quality Assurance across all regulated programs and process. The QA director will work alongside our Development and Operations teams, providing compliance in support of all Eureka GxP functions.
The Director of Quality will maintain and improve the Quality Management System (QMS) through continuous development, implementation and maintenance of quality standards, policies and procedures incorporating phase-based flexibility that ensure rigorous regulatory compliance. Additionally, the Director of Quality will be responsible for establishing a scalable quality system to support the future establishment of internal cGMP manufacturing capabilities.
- Performs gap assessment Quality Management System (QMS) processes including Change Control, Document Control, Risk Management, Deviations, CAPA, Training, Audits and Vendor Qualification.
- Establishes and maintains GxP training programs.
- Oversees internal and external audits for GMP activities.
- Identifies resource gaps and propose solutions.
- Collaborates with Clinical Operations functions to confirm adherence to GCP compliance through all stages of clinical trial conduct including but not limited to core study execution documents, clinical trial sponsor oversight, issue escalation and internal/external audit support.
- Oversees and manages the auditing process and other QA inspectional activities.
- Implements and maintains SOPs pertaining to Quality of GMP and GCP related activities.
- Provides oversight for inspections and audits of facility to understand how to ensure the build out is correctly managed.
- Manages vendors and contractors for facility maintenance and equipment calibration.
- Coordinates activities and leads interactions during regulatory agency inspections.
- Adjudicates issues with compliance concerns.
- Supports the Company's project teams and assists with project scheduling to assure that timelines and deadlines are met in the most efficient and economical manner
- Provides mentorship to ensure compliance with relevant regulations.
- Creates and manage project budgets.
Requirements and Qualifications:
- BS degree, or equivalent, in a pharmaceutical-related field with a minimum of 15 years of experience in Quality and/or manufacturing support, including at least 10 years of supervisory experience.
- Extensive internal and external auditing experience. Comprehensive knowledge of current Good Clinical Practices and the ability to correctly interpret GMP minimum standards.
- Strong verbal and written communication skills are required.
- Experienced in handling FDA inspections
- Proven ability to interpret regulations, to define and communicate strategy plans.
- Ability to work in a very dynamic environment of a scientifically driven biotech. Can evaluate and resolve complex problems and excels in planning and execution and utilizes resources wisely.
- The candidate should be a results-oriented team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues.
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.