Director Of Quality Assurance

Company: Staffing Theory
Location: Saint Petersburg
Posted on: June 23, 2022

Job Description:

Senior Director of Quality Assurance - St. Petersburg, FLA privately held clinical research organization in Florida is in need of a highly accomplished Quality Assurance professional to lead the overall strategy and conduct of Quality Assurance services within the company.Position Summary:This position reports to the President and works closely with the Executive Leadership Team to ensure that Quality Assurance activities are aligned with corporate goals. May serve as quality liaison and interact with sponsors, project teams, sites and vendors to maintain compliance and industry standards.Key Responsibilities:

• Participates in the development, implementation, and maintenance of clinical development and company strategies; this includes but is not limited to leadership in the areas of quality, compliance, and operational excellence in all aspects of clinical trial operations (e.g., clinical/medical, data management, clinical supplies, statistics, quality assurance, etc.)
• Oversee the Quality Management System (QMS)
• Develops, implements, and revises standard operating procedures (SOPs); monitors company and departmental compliance with SOPs
• Ensures operational processes, procedures, systems, and standards are adopted and implemented consistently across clinical trials
• ---Identifies process improvements within the company through monitoring of Key Performance/Quality Indicators (KPIs/KQIs); collaborates with internal and external stakeholders to ensure that gaps are addressed appropriately
• Develops and implements training programs; this includes but is not limited to interfacing with clinical operations teams for audits of internal processes; promoting collaboration to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guideline; and monitoring knowledge and understanding of training, systems, processes, and policies
• Identifies compliance concerns, including but not limited to reviewing SOP deviations that impact the company, conducting root cause analysis, and recommending solutions
• Oversees plans and processes for development of remedial actions and other improvement plans for Preventive Action Plans from audits and inspections; ensures follow up on the completion and implementation of required tasks
• Partners with external stakeholders to perform effective audits of vendors (e.g., CROs, investigator/clinical sites) to ensure documents are tracked and maintained within standards, including but not limited to trial master files, clinical study reports, protocols, etc.
• Plans, coordinates, controls, and implements continuous improvement of processes and systems to ensure the quality and compliance of studies; provides detailed feedback and change management guidance for quality improvements affecting processes
• Leads the inspection and audit management program, including but not limited to all inspection readiness activities, inspection conduct, and preparation of responses to regulatory entities
• Maintains understanding of new and emerging regulations; collaborates with stakeholders to implement regulations in an appropriate manner within the company's Quality Management System and practices.Minimum Qualifications:
  • BS/BA in Life Sciences, Pharmacy, or Nursing
  • Minimum 15 years experience in clinical research in the pharmaceutical or CRO/CMO industry, or similar organization with a GCP focus, with supervisory experience (prefer specialized knowledge of a therapeutic area)
  • Minimum 5 years in a management role within a Quality Assurance / Quality Management environment, to include auditing skills
  • Thorough knowledge and understanding of US and international regulatory requirements for clinical research
  • Demonstrated knowledge and application of clinical research processes and procedures; electronic documentation systems; GCP and GLP regulations and guidance; medical terminology; and effectiveness in maintaining clinical quality assurance control processes for compliance with regulations
  • Experience with clinical trial management systems (CTMS)
  • Able to handle sensitive and confidential information with discretionCompany Benefits:
    • Highly Competitive Compensation
    • 401(k) Profit Sharing Plan & Roth IRA
    • Comprehensive healthcare
    • Vacation + Flexible PTO
    • Flexible workplace to support work-life balanceThis position can be hybrid or fully remote, with travel to St. Petersburg, Fl once a month to confer with senior staff.We look forward to hearing from you!Sorry but there is no visa support for this position.

Keywords: Staffing Theory, St. Petersburg , Director Of Quality Assurance, Executive , Saint Petersburg, Florida