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Director, Clinical Quality Assurance RWE Clinical Trials

Location: Deerfield
Posted on: June 23, 2022

Job Description:

Job Summary

The Director, Clinical Quality Assurance for the RWE Clinical Trial business will be responsible to proactively assess and identify risks, provide leadership for the development of the new quality function, and expertise to ensure business is performing to Good Clinical Practice (GCP) standards. This role will also be responsible to provide quality assurance oversight and management activities of clinical trial operations and study protocols in accordance to GCP guidelines, applicable regulations and quality standards. The Director, Clinical Quality Assurance will work closely with the Senior Director, Regulatory Affairs, to develop the clinical trial quality framework to support the execution of clinical trials including individual clinical trial review plans to be delivered to internal and external project teams. The Director, Clinical Quality Assurance will be responsible to proactively identify and communicate key business or study risks and oversee action plans to mitigate the risks. The role will also be responsible for the monitoring and trending of quality issues, metrics, investigation, and CAPA management to ensure the clinical trials business is biopharmaceutical inspection readiness activities are in place. This role will also be responsible to ensure the internal Walgreens clinical trial study team members are prepared to represent GCP. Reports to Senior Director, Regulatory Affairs, RWE Clinical Trials

Job Responsibilities

  • Provide overall leadership for the clinical trial quality function and responsible to establish comprehensive clinical trial quality processes and systems
  • Lead the development, implementation, and communication for the overall quality strategic plan in line with GCP and other clinical trial regulations.
  • Responsible for writing and maintaining procedural documents (SOPs) to ensure clinicals business adheres to the industry regulatory standards (e.g., audit, CAPA and Quality Issue Management, regulatory inspections, quality risk management).
  • Accountable for the QA review of documentation and documents submitted to regulatory agencies, including IRBs, biopharmaceutical customers, and publications
  • For the assigned studies, leads quality issue investigations, root cause analysis and CAPA development and assist study teams in implementing corrective and preventive actions in support of sustainable compliance.
  • Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to GCP
  • Understand and interpret FDA agency policies and guidance as it pertains to the clinical trial work being conducted
  • Liaise with other Walgreens clinical trial team members and external parties including, physician and Walgreens sites and partners to promote high level of quality and consistency across and within clinical trials
  • Provide QA review of study protocols to identify operational risks and collaborates with study team in development of risk mitigation strategies.
  • Develops risk-based audit plans for assigned programs, ensures audits are conducted in accordance with the plan, reviews audit reports, evaluates responses and CAPA plans in accordance with SOPs
  • Leads the development and implementation of continuous quality improvement initiatives by establishing and tracking key performance quality standard metrics and utilizing data to embed continuous improvement principals across the clinical trials business
  • Perform ongoing review of existing policies and procedures (SOPs) identifies gaps, and leads the development of new and updated SOPs align with the current regulatory standards and Walgreens Corporate policies
  • Develop and mentor staff through on-boarding, open communication, training and development opportunities and performance management processes; build and maintain employee morale and motivation; ensure the team is appropriately staffed with required competencies; foster a diverse and inclusive workplace.An Equal Opportunity Employer, including disability/veterans

    About Walgreens Boots Alliance

    Walgreens Boots Alliance (Nasdaq: WBA) is a global leader in retail pharmacy, impacting millions of lives every day through dispensing medicines, and providing accessible, high-quality care. With more than 170 years of trusted healthcare heritage and innovation in community pharmacy, the company is meeting customers' and patients' needs through its convenient retail locations, digital platforms and health and beauty products.

    Including equity method investments, WBA has a presence in more than 25 countries, employs more than 450,000 people and has more than 21,000 stores.
    WBA's purpose is to help people across the world lead healthier and happier lives. The company is proud of its contributions to healthy communities, a healthy planet, an inclusive workplace and a sustainable marketplace. WBA is a participant of the United Nations Global Compact and adheres to its principles-based approach to responsible business.

    WBA is included in FORTUNE's 2021 list of the World's Most Admired Companies. This is the 28th consecutive year that WBA or its predecessor company, Walgreen Co., has been named to the list.

    More company information is available at

    Basic Qualifications
    • Bachelor's degree and at least 6 years OR High School/GED and at least 9 years biopharmaceutical, CRO, or other related industry
    • Experience in biopharmaceutical, CRO, or other related industry
    • Experience in a Quality and or Clinical Operations environment with expert knowledge and hands on experience with GCP audits
    • Knowledge of ICH GCP guidance for clinical development including operating in a real world evidence environment
    • Experience with all phases of clinical trial development involving drugs, biologics, devices and drug/ device combinations
    • Experience with management processes and requirements, including investigation, root cause analysis, CAPA plan development and effectiveness checks
    • Experience translating biopharmaceutical needs for innovation and creative approaches to quality management
    • Knowledge of scientific education and experience managing quality oversight for clinical trials, understands medical terminology, standards of care and disease states to assure the ethical treatment of subjects enrolled into trials
    • At least 2 years of experience contributing to financial decisions in the workplace.
    • At least 3 years of direct leadership, indirect leadership and/or cross-functional team leadership.
    • Willing to travel up to/at least 20% of the time for business purposes (within state and out of state).
      Preferred Qualifications
      • Master's degree
      • Proficient in using Microsoft Office applications is an asset (MS Word, MS Excel, MS PowerPoint, Visio)

Keywords: WALGREENS, Arlington Heights , Director, Clinical Quality Assurance RWE Clinical Trials, Healthcare , Deerfield, Illinois

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