Senior Director, Clinical Quality Assurance
Company: Allogene Therapeutics, Inc.
Location: South San Francisco
Posted on: June 7, 2021
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
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. You will be primarily
responsible for developing and spearheading Quality processes and
procedures supporting Good Clinical Practice (GCP), Good Laboratory
Practice (GLP), and Good Pharmacovigilance Practice (GVP)
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 relevant guidance documents
- Create and execute full clinical site qualification program
through development of GCP auditing system and partnership with
Clinical Operations team.
- Perform CRO supplier risk assessments and establish and execute
GCP, GVP, and GLP audit plans and compliance audits.
- Collaborate with the Clinical Operations team, CROs and sites
to effectively and efficiently set up the overall GCP and GVP
- Other 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, GVP, and GLP regulations and
the ability to correctly interpret minimum standards
- Proficient in MS Word, Excel, Power Point and other
- Comfortable in a fast-paced start-up environment with minimal
direction and able to adjust workload based upon changing
- Excellent organizational skills and an ability to prioritize
effectively to deliver results within reasonably established
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written
communication are essential in this collaborative work
- 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.
Keywords: Allogene Therapeutics, Inc., South San Francisco , Senior Director, Clinical Quality Assurance, Other , South San Francisco, California
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