Careers

Director, GCP/GLP/GVP Quality Assurance

Full Time
Gaithersburg, MD 20878
Posted 2 weeks ago

Arcellx (http://www.arcellx.com/) is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies.  The company has a team of biotechnology professionals with expertise in biologics discovery, characterization, and development.  Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells. Arcellx’s vision is to bring ARC-SparX cell therapies to millions of patients who can self-administer prescribed SparX proteins to treat their cancer under the care of academic and community practices.

Primary Objective:

Arcellx is looking for a Director of GCP/GLP/GVP Quality Assurance to be responsible for oversight of quality and compliance of Clinical, non-Clinical and Pharmacovigilance quality related activities.

Reporting to the VP of Quality, the Director will partner with the various internal and external stakeholders to ensure a high level of adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP/GLP/GVP requirements. The Director will play a key role in ensuring conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects are met. The Director will lead the efforts to identify potential compliance and operational risks to clinical trials and facilitate the development of mitigation plans.

Main Accountabilities:

  • Represent GCP/GLP/GVP Quality on project teams and act as the subject matter expert and a resource for GCP, GLP and GVP related items.
  • Act as the quality lead for the oversight of all quality aspects performed by CROs and external service providers.
  • Manage compliance risk assessments and facilitate root cause analysis, CAPA implementation and effectiveness checks.
  • Create, review, and approve GCP/GLP/GVP related documentation including but not limited to SOPs, study protocols, study reports, IB, study execution plans, clinical site selections, Safety Management Plans, PSMF, Aggregate reports, etc.
  • Develop, implement, and execute the audit strategy and Inspection Readiness plans for clinical programs.
  • Lead internal and external GCP/GLP/GVP audits.
  • Support Management Quality Reviews.
  • Prepare Key Performance and Quality Metrics.
  • Partner with the VP of Quality in creation of department goals and metrics.
  • Communicate and promote a culture of quality and operational excellence at Arcellx.

Requirements and Qualifications:

  • A Bachelor’s degree in a scientific or technical discipline is required. An advanced degree is preferred.
  • A minimum of 15 years of experience in a GxP biotechnology or pharmaceutical environment is required.
  • Extensive working knowledge of GCP related regulatory requirements US FDA, EU Directives and ICH guidelines, Pharmacovigilance (PV) regulatory guidance, and GLP guidelines.
  • Extensive working knowledge in development and implementation of GCP/GLP/GVP Inspection Readiness and audit programs, and participation in regulatory agency inspections.
  • Hands on experience in conducting clinical site and vendor auditing processes with recent FDA and EMA compliance requirements landscape.
  • Development and maintenance of compliance monitoring, GCP/GLP/GVP SOPs, and other process-related documents experience
  • Ability to critically evaluate and troubleshoot complex problems and attention to detail.
  • Ability to manage multiple priorities and aggressive timelines

Competencies:

  • Must have strong organizational skills and an ability to handle track and execute multiple priorities.
  • Highly motivated, with willingness to acquire new skills and ability to learn quickly.
  • Detail oriented, good documentation practices, technical writing and verbal communication skills
  • Possess problem solving and analytical skills and be an independent and creative thinker.
  • Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
  • Interpersonal and leadership skills to work with teams in different functions and organizations.

Submit cover letter and resume to: hr@nullarcellx.com

Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.

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