Senior Manager/Associate Director, Clinical Quality & Compliance
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.
The Senior Manager/Associate Director, Clinical Quality & Compliance is responsible to ensure quality and compliance of Allogene-sponsored clinical trials and related systems with respect to Allogene’s Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific), and current industry standards and practices.
We are seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast paced environment and share in our mission to help others. We are headquartered in South San Francisco (SSF) and this role will be based onsite in our SSF facilities, but this role may be remote, depending on candidate.
Clinical Quality Assurance (Clinical QA) at Allogene comprises QA oversight of Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Good Laboratory Practice (GLP), and Good Pharmacovigilance (GPvP) activities.
Responsibilities include, but are not limited to:
These may include but are not limited to:
- Ensure the quality and compliance of Allogene’s clinical activities with respect to internal procedures as well as FDA, ICH, EU and other country specific regulations
- Prepare and conduct or assist/oversee contract auditors for GxP audits per established strategies
- Audit, as required, and provide audit results to stakeholders and support process improvement activities as a subject matter expert (SME) in GCP/GPvP/GLP
- Support the development of internal systems for the maintenance of internal audit files, Tracking Log and related Clinical QA outputs/summaries/metrics.
- Establish contract agreements and Statement of Works (SOWs) with Clinical QA consultants, according to the internal process. with Allogene Legal input
- Conduct/oversee Clinical QA review of draft protocols; Informed Consent Forms, aggregate safety reports, clinical study reports and other clinical trial specific documents, when requested
- Conduct/oversee risk-based audits of service providers, internal systems and clinical investigators involved with Allogene clinical trial programs
- Conduct/oversee of regulatory training for GCP/GPvP/GLP as needed
- Conduct the review of clinical trial related SOPs
- Support efforts to enhance and establish a corporate-wide Quality Management System (QMS)
- Lead in the inspection readiness activities; attend clinical trial team meetings, provide Clinical QA advice, as necessary to clinical teams and functions
- Maintain working knowledge of FDA, EU and other global regulations and guidance governing GCP/GPvP/GLP.
- Maintain file organization within the Clinical Quality Assurance Department
- Other duties as assigned
Position Requirements & Experience:
- Minimum Bachelor’s degree in a healthcare or scientific-related discipline with 8 years for experience in GCP/GPvP/GLP quality assurance experience in a pharmaceuticals or biotechnology industry (an equivalent combination of experience and education may be considered)
- Excellent understanding of Clinical Development Process
- Experience writing and reviewing SOPs which support clinical trials
- Good understanding of FDA GCP and ICH regulatory requirements and implementation
- Good knowledge of Computer System Validation (CSV) in association with GCP/GPvP/GLP audits
- Good knowledge of clinical laboratory requirements and method validation
- Effective communication (verbal and written)
- Strong interpersonal skills, team player, and flexible without compromising quality
- Ability to manage multiple projects in a dynamic environment and ability to meet fast-track timelines
- An ability to be productive and successful in an intense work environment
- Experience with participating in global regulatory inspections
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.