Director, QA GCP Compliance in San Diego, CA

$$250K+(Ladders Estimates)

Arena Pharmaceuticals, Inc   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech


15+ years

Posted 38 days ago

This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.

We are seeking a Director, QA GCP Compliance who will report to the Director of Clinical Quality Assurance and will be responsible for ensuring compliance with Good Clinical Practice (GCP) / Good Manufacturing Practices (GMP) and compliance with established guidelines for regulatory standards for clinical studies, as well as company policies/procedures.

What you'll dive into:

  • Develop and maintain Quality Assurance Plans using the risk base approach for assigned drug development programs in conjunction with the appropriate clinical development staff
  • Attend project meetings, representing Clinical Quality Compliance and provide GCP insight and oversight
  • Manage and perform GCP audits: Investigational sites, various vendors supporting conduct of clinical studies, GCP system audits, clinical studies report, investigational brochure, etc
  • Develop, implement and maintain CQA internal systems, auditing metrics and tracking systems
  • Evaluate audit observations and trends and develop periodic compliance reports for management
  • Monitor and drive quality issues to resolution. (e.g., Closure of Audit Reports, develop and track post auditing corrective actions plans, as applicable)
  • Responsible for managing GCP compliance activities / non-conformances associated with assigned programs
  • Understand and interpret current pharmaceutical regulations and ICH guideline requirements pertaining to GCP and advise the Clinical development teams on all relevant issues
  • Develop, implement and maintain Clinical Quality Assurance SOPs in accordance with Corporate Standards and Policies
  • Review Clinical Development SOPs to ensure compliance with all applicable regulatory authorities as well as Corporate Standards and Policies.
  • Provide support prior to and/or during regulatory inspections, third party inspection
  • Work in conjunction with other Quality areas to ensure proper representation throughout the organization, as needed
  • Conduct internal system audits to ensure compliance with applicable regulations, SOPs and policies and advice on process improvements in the functional areas
  • Conduct training as applicable (e.g. Investigator's Meetings) and/or review materials provided by CRO to ensure required standards are met, and in alignment with Arena's processes
  • Manage the internal CQA audit process to assure compliance to Arena's SOPs
  • Provide support to ensure GCP compliance for clinical trial material (CTM)
  • Involved in the development, specification design, launch, and user acceptance testing of IWR/IVR Systems to support drug accountability at clinical sites and/or depots as applicable
  • Provide oversight of GMP activities relative to clinical trials - review of the design and translation of global CTM labels
  • Work closely with QA-GMP, Clinical Supply Manager in review and release of CTM batch records for secondary packaging/labeling.
  • Review and approve pharmacy manuals in accordance with protocols and investigational brochure
  • Perform un-blinded pharmacy monitoring for investigator's sites as required (Not involved in the conduct of the applicable clinical trial).
  • Attend applicable clinical supplies discussion with various departments
  • Work closely with Clinical Supply Manager to ensure clinical site to meet subjects' needs

What we expect:

  • Bachelor's degree
  • Minimum of 15 years within the pharmaceutical industry, including a minimum of ten years in research and development preferably as an GCP auditor/compliance advisor, clinical research associate/monitoring, data manager, clinical supply manager, and/or managing clinical sites
  • Experience managing Phase I - Phase IV programs
  • Experience and thorough knowledge of local and global regulations (e.g., FDA, EMEA, MHRA, etc.), clinical pharmaceutical research and development process and audit principles and practices
  • Demonstrating proficiency within ICH guidelines, especially GCP
  • Sound awareness and understanding of the pharmaceutical business, especially with regard to the Quality, Compliance and regulatory requirements of clinical development
  • Some experience and knowledge of GVP and GLP is a plus
  • Experience managing others
  • Proven leadership and management skills including problem solver
  • Ability to prioritize and manage multiple responsibilities
  • Able to communicate in a diplomatic, clear and efficient style
  • High degree of accuracy and attention to detail
  • Good judgment/analytical thinking: Able to differentiate between critical and non-critical issues and to then initiate the appropriate steps
  • Demonstrated leadership and, interpersonal skills as well as proven ability to work in a multi-disciplinary team setting including the ability to partner
  • Ability to work both independently and as part of a team
  • Travel domestically and internationally (up to 40% during peak workloads)

Valid Through: 2019-10-7