Associate Director/Director Clinical Quality Assurance
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 strong pipelines 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 Associate Director/Director Clinical Quality Assurance will have the responsibility for effectively identifying quality and compliance issues, be actively hands-on in resolving issues, recommending solutions, and providing Clinical QA guidance across functions at Eureka Therapeutics. In particular, the individual will be responsible for providing GCP/GLP compliance implementation, support to Clinical department and clinical study teams, and provide expertise guidance regarding regulatory requirements. This position reports to the Chief Medical Officer and will be an integral part of the clinical team.
- Take risk-based strategy to set direction and prioritize Clinical QA support for clinical trial activities. Identify and escalate compliance issues, influence the development and implementation of strategies to close the gaps.
- Responsible for effectively identifying quality and compliance issues, actively resolving issues, recommending solutions, and providing Clinical QA guidance across functions.
- Provide program and clinical study teams with relevant analyses and guidance on the interpretation and application of GCP/GLP regulations to ongoing clinical development activities.
- Develop Clinical Quality Systems (CQS) and promote GCP/GLP quality activities & initiatives that improve process efficiencies and compliance (SOPs/ Training).
- Perform CRO supplier risk assessments in support of QA Vendor Qualification program.
- Establish audit plans and annual CQA Audit Plan. Plan and execute GCP and GLP compliance audits, including clinical investigator sites, contract clinical laboratories and CROs; to determine compliance status and identify compliance risks.
- Provide teams with GCP/GLP audit results regarding the conduct of clinical or non-clinical studies and make appropriate recommendation.
- Conduct QA reviews of Clinical Development essential documents (e.g. protocols, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
- Represent CQA on clinical study execution and inspection readiness teams.
- Identify and escalate significant compliance issues, including the assessment of serious breaches and implement mitigation plan.
- Host and participate in relevant external and regulatory authority inspections. Respond to and resolve issues relating to inspection findings. Provide GCP/GLP training to functional areas and ensure the content satisfies regulatory requirements and GCP Guidelines.
- Keep current on changes in industry and regulatory standards for GCP/GLP requirements and advise on business impact.
- Personally participate in supporting working groups and project teams regarding quality improvement initiatives and projects.
- Other potential projects when assigned.
- BS/BA degree in a scientific field required; advanced degree is a plus.
- A minimum of 8 years in biotech/pharmaceutical industry, with 5+ years of Clinical and/or Quality Assurance experience with active involvement and deriving the QA projects
- Comprehensive knowledge of GCP/GLP regulations and the ability to correctly interpret minimum standards are a must.
- In-depth knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations and guidelines.
- Track records in planning and conducting GCP and GLP audits.
- In-depth experience with regulatory inspections and inspection readiness.
- Experience with Quality Systems (e.g. deviations, investigations, and CAPA programs).
- Extensive experience with clinical/non-clinical operations for the execution of studies.
- Working knowledge in statistics, and computer-based operations to support clinical study execution.
- Experience with eTMF documentation systems.
Personal and Leadership Competencies:
- Excellent interpersonal and management skills, including clear, succinct and timely communication and proven ability to foster relationships with business stakeholders.
- Excellent oral and written communications skills.
- Detail-oriented, analytical, and ability to make independent decisions.
- Excellent organizational skills, with ability to lead and manage multiple priorities.
- Strong influencing skills and collaborate with cross-functional teams effectively
- Ability to apply knowledge and experience to new situations. Has the flexibility and willingness to solve problems that fall outside of immediate area of expertise.
If you are interested in applying for this opportunity, 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.