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Sr. Manager, (GCP Clinical) Quality Process & Standards

Company: Biogen
Location: Cambridge
Posted on: January 16, 2022

Job Description:

Job Description

About This Role:

As a Sr Manager, GCP Clinical Quality Process & Standards, you will provide end to end quality oversight of activities executed within Global Clinical Operations (GCO) including studies, programs, and processes, and contribute to GCO audit / inspection planning, management, and response generation.

You will be responsible for driving a culture of quality within GCO and will serve as an advocate for the Quality Management System (QMS). You will act as the Functional Quality Representative (FQR) for GCO, liaising with the R&D Quality / Compliance team and other FQRs, and operate within the define quality governance structure.

You will provide leadership and expertise for investigations of potential or actual quality issues pertaining to GCP and escalate as necessary per the quality governance pathway. In consultation with GCP stakeholders, you will determine the overall risk for quality issues, and facilitate the execution of CAPAs as required, including the evaluation of the adequacy of the CAPAs / Effectiveness Checks. Additionally, you will lead Study Risk Assessments and be actively involved in pro-active inspection readiness activities.

What You'll Do

  • Supporting the maintenance and development of the QMS by:
  • Reviewing GCO process deviations for compliance and completeness.
  • Participating in process improvements and functional initiatives, as required.
  • Reviewing and assessing controlled documents for possible gaps with respect to quality, compliance, and regulatory commitments.
  • Engaging with Process Owners / Sub-Process Owners or functional area leads to review Key Quality Indicators/ tolerance thresholds and communicate quality and compliance risks.
  • Overseeing and supporting Quality Management within the GCO Function:
  • By identifying process / functional risks and issues and mitigation strategies, determine requirements for escalation and communication to functional/quality leadership.
  • Providing consultation on quality questions / issues for programs and studies.
  • Monitoring functional metrics to assess compliance with processes and procedures and evaluating for potential quality signals / trends.
  • Implementing quality process reviews as needed.
  • Overseeing and approving CAPAs / Effectiveness checks.
  • Acting as quality liaison with vendor quality representatives as needed.
  • Involvement in audit and regulatory activities:
  • Contributing to audit planning and management of audit responses.
  • Conducting site and sponsor inspection preparation for GCO, identifying key risks and mitigation strategies, coordinating site inspection management activities, and facilitating inspection responses as appropriate.
    Qualifications

    Required Skills:
    • Bachelor's Degree
    • 5+ years' experience in clinical operations and / or compliance or quality function or equivalent including onsite experience (clinical monitoring/investigator site auditing)
    • In depth understanding of GCP and global regulations and standards that govern the development of clinical products (CFR, ICH, EU Directives, as examples)
    • GCP and regulatory clinical trial inspections
    • Understanding of quality by design, risk assessments, quality measures and metrics
    • Excellent written and verbal communication skills, including strong ability to facilitate meetings / discussions and influencing without direct authority
    • Ability to manage change and lead in an evolving organization
    • Judgment and decision-making skills
      Preferred Skills
      • Master's or Advanced Degree
        Additional Information

        Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us---as---a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

        All your information will be kept confidential according to EEO guidelines.

Keywords: Biogen, Cambridge , Sr. Manager, (GCP Clinical) Quality Process & Standards, Executive , Cambridge, Massachusetts

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