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Director Quality Improvement And Compliance Regulatory Science - Remote

San Francisco, CA
Closing date
Jan 18, 2022

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We are a diverse team that is united by this common purpose and we are hiring the world's best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career at one of the fastest growing companies is compelling, read on for more details.

Role And Responsibilities:

We are seeking a Director Quality Improvement and Compliance Regulatory Science to serve as the primary liaison between RegSci and Quality for Regulatory Compliance including ICH GCP guidelines, GxP guidelines, ISO 17025, Juul Labs Policies and Procedures, Standard Operating Procedures (SOPs) and current industry standards and practices. This position reports in the VP New Product Science and will work closely with the Director of Clinical Operations.
  • Will be responsible for activities to ensure Regulatory Compliance of human research and clinical trials with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Juul Labs Policies and Procedures, Standard Operating Procedures (SOPs) and current industry standards and practices.
  • Coordinates and manages Data Safety Monitoring Board review for pre-market products
  • Actively participates in the internal compliance quality reviews of research studies through the Research Review and Approval Committee.
  • Work with quality assurance programs to maintain GCP compliance and inspection readiness with the Clinical Quality Lead.
  • Provide effective management and serve as a primary contact for internal and Regulatory Agency Inspections.
  • Lead root cause analysis activities for any inspection findings identified and support the business in development of responses.
  • Responsible for the planning, coordination, oversight and continuous improvement of processes and methods to ensure conformance to internal and external quality standards, monitoring compliance trends.
  • Developing training programs and tools consistent with organizational needs.
  • Assist the research teams in effective Corrective and Preventive Plan (CAPA) and/or Quality Incident documentation and implementation.
  • Responsible for creation, development, stakeholder review, and management of Standard Standard Operating Policies and Work Instructions.
  • Acts as resource to the research departments with regard regulatory compliance and quality by design.
  • Fosters effective relationships that enhance department objectives.
  • Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various research projects involving investigational or marketed products.
  • Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for research projects in relation to annual and post market reporting.
  • Support regulatory chemistry group as needed with compliance and/or quality training, support, review of documents/data.
  • Perform other related duties as assigned.
  • Function as a regulatory compliance project manager liaising with the other functional groups.
  • In collaboration with the Director of Clinical Operations, manages all aspects of clinical research compliance from project proposal, through study conduct, data analysis and close out.
  • Manages multiple projects concurrently in a dynamic environment.

Personal And Professional Qualifications:
  • Masters degree or PhD in a health related field or ; OR an equivalent combination of education and experience
  • One (1) year of experience in program coordination, and Five (5) years clinical experience.
  • Excellent English language oral and written skills
  • Strong organizational skills, ability to handle multiple tasks and challenges simultaneously
  • Demonstrated ability to read and interpret documents
  • Extensive working knowledge of activities related to regulatory affairs, clinical quality assurance, both domestic and international for investigational and marketed tobacco products.
  • Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff and across functional boundaries
  • Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
  • Comprehensive knowledge of US Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Quality Systems Management (ISO 13485) and Good Laboratory Practices (GLP) requirements, ISO 17025 (Testing and Calibration Labs)
  • Excellent written and verbal communication skills.
  • Exceptional ability to conceptualize, develop and manage timelines.
  • Ability and willingness to travel internationally.
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