Senior Director, Clinical Quality Assurance
Quality | South San Francisco, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
We are seeking a highly motivated individual for the role of Senior Director, Clinical Quality Assurance (CQA) at Allogene Therapeutics. This is a hands-on role where you will provide quality oversight to all clinical operations and clinical trials sponsored by Allogene Therapeutics.
Responsibilities include but are not limited to:
- Develop and implement GCP quality oversight systems through development of standard operating procedures and work instructions that follow 21 CFR Part 50, 56 and 312 along with ICH E6 and other relevant guidance documents
- Lead efforts to develop and implement full clinical site qualification program through development of GCP auditing system and partnership with Clinical Operations team.
- Perform CRO supplier risk assessments in support of QA Vendor qualification program. Establish audit plans and annual CQA audit plan. Execute GCP and GLP compliance audits, including clinical investigator sites, contract research organizations (CROs) and contract clinical laboratories to determine compliance status and identify compliance risks.
- Conduct QA reviews of essential Clinical Development documents (e.g. protocols, informed consents, investigator brochures, clinical study reports, etc.)
- Participate in the development of clinical site training systems and help to develop the site certification process related to cellular therapy processes
- Collaborate with the Clinical Operations team, CROs and sites to effectively and efficiently set up the overall GCP oversight programs
- Responsible for providing GCP and compliance related advice to internal clinical study teams and as well as maintaining CQA confidential files and SOPs.
- Responsible for effectively identifying quality and compliance issues, actively resolving issues, recommending solutions and providing Clinical QA guidance across functions.
- 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.
- Develop and provide independent periodic reports to management on overall compliance status
- Assist team in the creation of personal goals and monitor performance
- Other Quality-related duties as assigned
- Bachelor’s Degree in a scientific or related discipline with advanced degree preferred
- 10+ years of experience in a GCP quality role, with at least 3 years leading the GCP function
- Comprehensive knowledge of GCP/GLP regulations and the ability to correctly interpret minimum standards
- Knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations and guidelines.
- Experience in clinical trials with biologics and with t-cell immunotherapies highly preferred
- Cold chain (including vapor phase) knowledge in a pharmaceutical or medical setting
- Experience with hosting regulatory inspections and performing inspection readiness planning and execution activities.
- Experience in GCP audits either through performing audits or being the recipient of the audit
- Experience with Quality Systems (e.g. deviations, investigations and CAPA programs)
- Proficient in MS Word, Excel, Power Point and other applications
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.