We are seeking a highly motivated individual for the role of Senior Director, R&D Quality at Allogene Therapeutics. This is a key leadership role which provides strategic direction and oversight for the establishment and iterative improvement of the R&D (GLP, GCLP, GCP, GVP) quality program. The incumbent will partner with stakeholders across R&D (e.g. Clinical Development, Clinical Operations, Biostats/Data Management, Translational Sciences and Drug Safety/Pharmacovigilance) to develop the GxP Quality Management System and define the quality oversight model for internal operations and those conducted at CROs/vendors. The incumbent will be responsible for the hiring and development of the R&D Quality team in alignment with the growth of the business and clinical programs.
Responsibilities include but are not limited to:
- Provide Quality oversight for development, clinical trial and pharmacovigilance activities. Assess activities conducted internally and outsourced to CROs/vendors to ensure practices are compliant with relevant cGxP (GLP, GCLP, GCP, GVP) requirements and expectations.
- Partner with R&D stakeholders to establish and maintain the GxP Quality Management System. Conduct gap assessments and establish quality plans to drive continuous improvement.
- Support selection, management, and inspection readiness of CROs/vendors by performing audits, gap assessments and quality system/operational reviews.
- Interact with Quality Units of CROs/vendors to ensure Sponsor quality interests are met and that high performing relationships are maintained. Contribute to establishment of relevant CRO metrics.
- Develop and execute R&D/Clinical Audit Plan. Integrate activities into the Allogene GxP annual audit schedule and processes. Execute audits and provide oversight of 3rd party auditors. Review and approve CRO audit reports and action plans.
- Support clinical study teams during generation and closure of deviations, investigations and CAPAs
- Review and approve internal and CRO quality plans and records (e.g. Quality Plans, Risk Management Plans, quality incidents/investigations, CAPAs, etc) to assure documentation is scientifically sound, justified as appropriate, and meets cGxP requirements and expectations.
- Work with cross-functional colleagues to establish relevant Management Review metrics and Quality Review forums to manage/escalate quality issues and foster a culture of continuous improvement.
- Lead R&D inspection readiness and execution activities. Host GLP, GCLP, GCP, GVP inspections. Lead the development of responses and remediation of gaps. Represent Sponsor to support regulatory inspections and responses at CROs/vendors and clinical investigator sites.
- Partner with internal Quality peers to ensure GxP processes and systems meet the needs and requirements of R&D stakeholders (e.g. audit management and inspection readiness; deviations, CAPAs and root cause analysis).
- Support the preparation and review of Regulatory submissions and relevant source documentation.
- Direct, plan, delegate and manage the R&D Quality function. Ensure the hiring and development of a highly effective R&D Quality team. Execute people management and talent development activities.
- Routinely scan external environment and engage in industry forums to proactively identify and implement cGxP practices and technologies. Represent company to provide voice and leadership for innovative cell therapy needs.
- Act as a catalyst to foster risk-based decision making and quality/responsible mindset and behaviors across Allogene.
- Execute other functional or company-wide projects or initiatives as assigned
- Bachelor’s Degree in a scientific or related discipline with advanced degree preferred
- 12+ years of experience in clinical trial management, drug safety/pharmacovigilance or quality oversight roles in the bio/pharmaceutical industry, with at least 3 years leading a GLP, GCLP, GCP and/or GVP function
- Comprehensive knowledge of GLP, GCLP, GCP and GVP regulations and the ability to interpret in a phase-appropriate and risk-based manner in an innovative cell therapy landscape.
- Strong experience auditing GxP (GLP, GCLP, GCP, GVP) processes and systems
- Experience leading inspection readiness activities and hosting GLP, GCLP, GCP and/or GVP inspections
- Experience establishing a Quality Management System
- Excellent interpersonal skills with a demonstrated track record of establishing productive cross-functional relationships and high performing teams
- Excellent verbal and written communication skills; highly diplomatic
- Demonstrated ability to execute independently and effectively represent Quality in a fast-paced cross-functional team settings. Able to adjust workload based upon changing priorities.
- Ability to deal with ambiguity; demonstrated creative and pragmatic approach to problem solving
- Proficient in MS Word, Excel, Power Point and other applications
- Candidates must be authorized to work in the U.S.